The Bakery at Walmart 8 Count Crullers Net Wt 10 oz (0.62 lb), UPC 0007874298471, Item Number 9832404. Recall # F-0849-2012

All products with expiration dates on or before Feb. 09, 2012.

Recalling Firm: Walmart Stores, Inc., Bentonville, AR, by e-mail on February 7, 2012 and by press release on February 11, 2012.

Manufacturers: Walmart Stores, Inc., Bentonville, AR;

Dawn Mixco International, Santa Catarina, Mexico. Firm initiated recall is ongoing.

The product label declares sodium caseinate but does not list milk as required by FALCPA.

8,732 units

Nationwide

1) Rain brand Swiss Roll (banana flavor), Net Weight: 160g (5.64 oz), UPC 6 921682 823593, PRODUCT OF CHINA -- Firms on label: S&M (HK) ENTERPRISE LTD. Recall # F-0851-2012;

 

2) Rain brand Swiss Roll (strawberry flavor), Net Weight: 160g (5.64 oz), UPC 6 921682 823609, PRODUCT OF CHINA --- Firms on label: S&M (HK) ENTERPRISE LTD. Recall # F-0852-2012;

 

3) Rain brand Swiss Roll (coconut flavor), Net Weight: 160g (5.64 oz), UPC 6 921682 823616, PRODUCT OF CHINA --- Firms on label: S&M (HK) ENTERPRISE LTD. Recall # F-0853-2012

None

Recalling Firm: S&M (USA) Enterprise Corp., Brooklyn, NY, by press release on April 13, 2011 and April 20, 2011 and by letters dated April 13, 2011 and April 20, 2011.

Manufacturer: Fujian Fuma Foods Group CO., Jinjiang, China. New York initiated recall is complete.

The product contained undeclared eggs based on sampling and analysis by New York State Department of Agriculture & Markets.

Banana flavor: 752 cases; Strawberry flavor: 677 cases; Coconut flavor: 586 cases

NY City area

Rexall liquid filled absorbable Calcium 1200 mg plus 1000 IU Vitamin D3 per serving --- 60 Softgels, Dietary Supplement --- UPC: 301220452113 --- Product No. 45211. Recall # F-0859-2012

Lot 387651-04, expiration 08/15

Recalling Firm: NBTY, Inc., Bohemia, NY, by press release on January 6, 2012 and letters on January 17, 2012.

Manufacturer: NBTY, Inc., Boca Raton, FL. Firm initiated recall is ongoing.

Rexall brand Calcium 1200mg liquid softgels 60-count bottles; actually contain Glucosamine Chondroitin with MSM tablets.

13,608 bottles

Nationwide

Bin Bin Snow Rice Crackers, Net Wt. 5.3 oz (150g), UPC 852098700124; Bin Bin Snow Rice Crackers Net Wt. 15.8 oz, bulk pack (150g), UPC 8520098701510. Recall # F-0860-2012

None

Recalling Firm: Summit Import Corp., Jersey City, NJ, by press release dated February 9, 2012 and letters on February 10, 2011.

Manufacturer: Namchow (Thailand) Ltd., Ratchaburi. Thailand. Firm initiated recall is ongoing.

Bin Bin crackers may contain undeclared egg.

225 cases 5.3 oz bags; 601 cases 15.8 oz bags

Nationwide

Dried fish Vobla gutted, weight 0.594 kg, Product of Germany. The product is vacuum packed in a sealed, plastic bag. Production date: 21.06.2010. Recall # F-0862-2012

Lot # 280610140

Recalling Firm: S&S Food Inc., Brooklyn, NY, by press release on December 6, 2010 and letters dated December 7, 2010.

Manufacturer: Qualitat fisch Kompass international GmbH, Preussisch Oldendorf,
Germany. New York initiated recall is complete.

The processed fish was found to be improperly eviscerated based on sampling and analysis by New York State Department of Agriculture & Markets.

403 cases (approx. 22 lbs. per case)

NY, IL, CA, WA

 

AquaHydrate Bottled Water. The affected product is bottled water sold in 500 mL and 1000 mL bottles. Production Information: 8/3/11, 8/4/11, 8/16/11, 8/17/11, 8/25/11, 8/31/11, 9/1/11, 9/13/11, 9/14/11, 9/21/11, 9/27/11, 10/5/11, 10/6/11, 10/7/11, 10/8/11, 10/26/11, 10/27/11, 11/9/11, 11/10/11, 12/8/11, 12/9/11, 12/10/11. 500 ml Case UPC 182136000038 (Canadian Case UPC 182136000342) 500 ml Unit UPC 182136000014 1000 ml Case UPC 182136000045 (Canadian Case UPC 182136000366) 1000 ml Case UPC 182136000021. Recall # F-0850-2012

None

Recalling Firm: AquaHydrate, Inc., Colton, CA, by telephone on December 29, 2011, and by e-mail and letter on December 30, 2011

Manufacturer: Creative Bottling, Corona, CA. Firm initiated recall is ongoing.

The product may contain plastic pieces.

39,994 cases

Nationwide and Canada

1) Needmore Oatcakes, each batch hand-made locally. Chocolate Chip Walnut Oatcakes, Ingredient: Rolled oats, semi-sweet chocolate chips water, whole wheat flour, walnuts, water, unsalted butter, turbinado sugar, sea salt. Net Weight 5.3 oz /150 grams. Recall # F-0855-2012;

 

2) Needmore Oatcakes, each batch hand-made locally. Cranberry-Orange Oatcakes, Ingredient: Rolled oats, whole wheat flour, sweetened dried cranberries, orange juice from concentrate, water, unsalted butter, turbinado sugar, imitation vanilla extract, sea salt. Net Weight 5.3 oz /150 grams. Recall # F-0856-2012;

 

3) Needmore Oatcakes, each batch hand-made locally. Date Oatcakes, Ingredient: Rolled oats, chopped dates rolled in oat flour, whole wheat flour, water, unsalted butter, turbinado sugar, and sea salt. Net Weight 5.3 oz /150 grams. Recall # F-0857-2012;

 

4) Needmore Oatcakes, hand-made locally. Ginger-Almond Oatcakes, Ingredients: Rolled oats, crystallized ginger, whole wheat flour, water, unsalted butter, turbinado sugar, sea salt. Net Weight 5.3 oz /150 grams. Recall # F-0858-2012

1) Exp. date 2/8- 2/13;

2) – 4) Exp. date 2/8- 2/15

Needmore Oatcakes, Nashville, IN, by visit and letter beginning February 8, 2012. FDA initiated recall is ongoing.

Oatcakes contain undeclared milk which is present in the butter ingredients.

130 units

IN

Portico Simply Brand 4 oz Vacuum Packed Mahi Portions. Master Case was labeled in part: "***12721PMD IMPORTANT: THAW UNDER REFRIGERATION ***IMMEDIATELY PRIOR TO USE. ***INGREDIENTS: Mahi-Mahi***CONTAINS: Mahi-Mahi***WILD CAUGHT PRODUCT OF PANAMA*** FACILITY REGISTRATION FDA # 14048801796***NET WT 10 LBS (4.55 kg) PLANT No. 192***PDMHO2740ZPSCGLAV1/10LB** 1/10 LB MAHI MAHI PORTIONS BONELESS AND SKINLESS VACUUM PACKED 4 oz***" Master Label is labeled in part: "***P***PORTICO***SEAFOOD***Simply***PERISHABLE KEEP FROZEN 0 F OR BELOW. Recall # F-0861-2012

None

Recalling Firm: Marpesca Direct LLC, Tampa, FL, by telephone and email beginning February 3, 2012.

Manufacturer: Procesadora Marpesca, S.A., Arraijan, Panama. Firm initiated recall is ongoing.

Product sample tested positive for Histamine greater than 50 ppm.

300 cases

MD, PA, KS, and WI

Safeway Refresh Purified Drinking Water; Enhanced with Minerals for Fresh Taste 500 mL/ 16.9 Fl oz plastic bottle; UPC 00 021130 24032, 24 x 500 mL bottles per case and 2) 6 pack, UPC 00 21130 24043; 3) UPC 00 21130 24030 - 500mL bottle. Recall # F-0863-2012

1) 24 pack with best by dates beginning with 8/26/13 up to and including 01/19/2014 with designation S8245; 2) 6 pack with best by dates 9/23/13, 9/26/13, 11/17/13 with desgination S8245. 3) With best by dated 8/26/13 up to and including 01/19/114 with designation S8245.

Recalling Firm: Safeway Inc., Pleasanton, CA, by e-mail on February 9, 2012.

Manufacturer: Safeway Inc., Merced, CA, Firm initiated recall is ongoing.

A small quantity of individual packages of Refresh Purified Drinking Water may contain slivers of plastic up to 12 mm in length.

1,614,708 cases

CA, NV, HI

 

Utz White Round Tortilla Chips, No Salt, 12 oz bag, UPC 4149700451. Recall # F-0854-2012

MAR 24 12 A1

Utz Quality Food Inc., Hanover, PA, by email on February 7, 2012. Firm initiated recall is ongoing.

Mislabeled - unsalted labeling was used for salted product.

95 cases of 7 bags

MD, NJ, PA and WV

 

 

 

NONE

 

 

VALPROIC ACID ORAL SOLUTION, USP, 250 mg/5 mL, 16 fl oz (473 mL), Rx only, NDC 50383-792-16 (Hi-Tech label), and NDC 0591-0426-16 (Watson label). Recall # D-1262-2012

Lot 604482, exp. 1/2013

Hi-Tech Pharmacal Co., Inc., Amityville, NY, by telephone on December 8, 2010 and December 14, 2010, and by letters dated December 8, 2010. Firm initiated recall is ongoing.

Failed pH Specification: OOS pH (low) resulted in OOS description for cloudy, hazy, oily appearance of the product.

15,252 bottles

Nationwide and PR

Phenylephrine HCl Injection, USP, 1% (10 mg/mL) (50 mg/5 mL), 5 mL Vial, For Pharmacy Use Only, For SC, IM, or IV use, Rx Only, NDC 0517-0405-25. Recall # D-1264-2012

Lot #: 0693, Exp: 10/2012

Luitpold Pharmaceuticals, Inc., Shirley, NY, by press release, email, and/or fax and letter dated February 22, 2012. Firm initiated recall is ongoing.

Presence of Particulate Matter: One lot of Phenylephrine HCl Injection, USP, 1%, is being recalled due to the identification of visible particles found in some retain samples of this lot.

150,575 Vials

Nationwide

Vidaza (azacitidine for injection), 100 mg Single-Use Vial, for Subcutaneous and Intravenous Use Only, Rx Only, NDC 59572-102-01. Recall # D-1265-2012

Lot numbers for product distributed to the following countries: Japan - Lot #: 100401, Exp. Jun-14; Switzerland - Lot #: 1345069B, 1345070B, 1345073A, Exp. Dec-11; 1345088A, Exp. Apr-12; 1859672B, 1599082B, Exp. Apr-13; 1859679A, 1859677A, Exp. Jan-14; Poland - Lot #: 1602514B, Exp. Apr-13; Turkey - Lot #: 1345069A, Exp. Dec-11; 1345088B, 1345088C, Exp. Apr-12; 1859672A, Exp. Dec-13; 1599082A, Exp. Apr-13; 1859677B, Exp. Jan-14; 1859679B, Exp. Feb-14; Hong Kong - Lot #: 1907405, Exp. Mar-14; 1907418, Exp. Jul-14.

Recalling Firm: Celgene Corp., Overland Park, KS, by press release on November 22, 2011 and e-mail between November 23/30, 2011.

Manufacturer: Ben Venue Laboratories Inc., Bedford, OH. Firm initiated recall is ongoing.

Lack of Assurance of Sterility; During an inspection conducted at BVL (the manufacturing firm) by multiple regulatory authorities, including the FDA, manufacturing and quality concerns were identified, including sterility assurance concerns, therefore, this product is being recalled because the manufacturing firm cannot assure sterility of the product.

106,579 Vials

International only

Aveeno Baby Calming Comfort Lotion Net Wt. 8 oz. (227 g). Made in Canada, NDC 58232-0211-1. Recall # D-1266-2012

Lot #0161LK

Recalling Firm: Johnson & Johnson, Skillman, NJ, by letter dated January 26, 2012 and press release on January 27, 2012.
Manufacturer: Les Emballages Knowlton Inc., Knowlton, Canada. Firm initiated recall is ongoing.

Microbial Contamination of Non-Sterile Products: Product recall due to a potential for microbial (coagulase negative staphylococci) contamination.

2,208 tubes

Nationwide

Flutamide Capsules USP, 125 mg, Rx Only, 180-count bottle, NDC 0172-4960-58. Recall # D-1267-2012

Lot #s: J05761, Exp 11/2012; J15067, Exp 1/2013; J15229, Exp 4/2013

Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letters on January 24, 2012.

Manufacturer: Cipla Ltd, Verna, Salcette, Goa, India. Firm initiated recall is ongoing.

Adulterated Presence of Foreign Capsule; The firm received a complaint that a Flutamide 125 mg capsule, 180-count bottle had a foreign capsule identified as Imatinib Mesylate 100 mg capsule.

7,260 bottles

Nationwide and PR

 

Brimonidine Tartrate Ophthalmic Solution 0.2% (Sterile), Each mL Contains Active: Brimonidine tartrate 0.2% (Sterile), 15 mL bottles, Rx only, NDC 24208-411-15. Recall # D-1263-2012

Lot # 139961

Bausch & Lomb, Inc., Tampa, FL, by letters on February 22, 2012. Firm initiated recall is ongoing.

Impurity/Degradation; 9 month stability.

18,137 bottles

Nationwide and PR

Source Plasma. Recall # B-0730-12

Units: 08BWAB5793, 08BWAB2582, 08BWAB1907, 08BWAB0521, 08BWAA9012, 08BWAA8517

Recalling Firm: BioLife Plasma Services, L.P., Deerfield, IL, by facsimile on June 5, 2008.

Manufacturer: BioLife Plasma Services, L.P., Bellingham, WA. Firm initiated recall is complete.

Blood products, collected from a donor with a history of high-risk behavior, were distributed.

6 units

Austria

Red Blood Cells. Recall # B-0771-12

Unit: Y17928

Tacoma Pierce County Blood Bank, Tacoma, WA, by telephone on September 17, 2007. Firm initiated recall is complete.

Blood Product, collected from a donor whose donor suitability was not adequately determined, was distributed.

1 unit

WA

Source Plasma. Recall # B-0772-12

Units: 4550105219; 4550104956; 4550104388; 4550104102; 4550103552; 4550103355; 4550102758; 4550101829; 4550101599; 4550101073; 4550100736; 4550100248; 4550099951; 4550099298; 4550099089; 4550098555; 4550098334; 4550102377; 4550094629; 4550094871

Octapharma plasma, Columbia, SC, via e-mail on July 1, 2011. Firm initiated recall is complete.

Blood products, collected using an abbreviated screening process for which donors were not eligible, were distributed.

20 units

Austria

Red Blood Cells Leukocytes Reduced. Recall # B-0773-12

Unit: W044711064483

Rex Hospital, Inc., Raleigh, NC, by letter dated May 23, 2011. Firm initiated recall is complete.

Blood product, collected from a donor whose health history was not adequately performed, was distributed.

1 unit

NC

Upstate New York Transplant Services, Inc--Cornea preserved in Optisol GS—Donor #084960S. Recall # B-0780-12

Unit: 08496OS

Upstate New York Transplant Services, Buffalo, NY, via telephone and letter dated August 19, 2008. Firm initiated recall is complete.

Human cornea, recovered from a donor whose donor eligibility was based in part on a hemodiluted sample, was distributed.

1 cornea

NY

Bone - Allograft Cancellous Cubes from donor PS-4911-2006. Representative Labeling - Product was labeled in part: "***UNIVERSITY OF MIAMI SCHOOL OF MEDICINE***Tissue Bank***Department of Orthopedics and Rehabilitation R-12 ***HUMAN FREEZE-DRIED TISSUE***Deposit Number: B -235546-000-2006***Description-Size: CANCELLOUS CUBES 15 cc***Measurements:***Date: 01/02/07 Expiration: 09/11/11***Procurement No.: PS -04911-2006***CONTENT ASEPTIC 'SEE PACKAGE INSERT FOR SINGLE PATIENT USE ONLY SEE INSERT FOR RECONSTITUTION RECOMMENDED STORAGE: Room Temperature***". Recall # B-0781-12

Units: B235546000, B235546001

University of Miami Miller School of Medicine Tissue Bank, Miami, FL, by telephone on February 16, 2007. Firm initiated recall is complete.

Bone allografts, associated with positive final culture results, were distributed.

2 units

FL, OK

Cornea - Product is labeled in part: "***FLORIDA LIONS EYE***CORNEA CAP IN GLYCERIN***FLEB#07-09-030*** SINGLE PATIENT USE ONLY NOT STERILE DO NOT FREEZE***". Recall # B-0782-12

Units: 0709030CODPC, 0709030COSPC

Florida Lions Eye Bank, Miami, FL, by letter dated September 28, 2007. Firm initiated recall is complete.

Human Corneas, recovered from a donor whose donor eligibility determination was based on incomplete donor testing for relevant communicable disease agents or diseases, were distributed.

2 units

FL

ALLERGENIC EXTRACT, SPECIAL MIXTURE, 1 STERILE MULTIPLE DOSE VIAL 50 mL --- RX Only. Recall # B-0784-12

Lot # 5C46392, 5x50mL exp 10/14/2006; Lot # 4L46622, 5x50mL exp10/14/2006; Lot # 4L46632, 5x50mL, exp 10/14/2006; Lot # 4L46642; 5x50mL, exp 10/14/2006; Lot# 4H47782, 10x50mL exp 1/31/2006; Lot# 4J11932, 10x50mL exp 1/31/2006

Alk-abello, Inc., Port Washington, NY, by telephone on April 27, 2005. Firm initiated recall is complete.

Special mixture allergenic extracts, with decreased potency, were distributed.

40/50mL vials

OH

1) Red Blood Cells Leukocytes Reduced. Recall # B-0785-12;

2) Recovered Plasma. Recall # B-0786-12

1) and 2) Unit: 21LH25116

American National Red Cross, Portland OR, by facsimile and electronic notification on January 27, 2006 and by letter dated February 10, 2006. Firm initiated recall is complete.

Blood products, collected from a donor who received a tattoo within one year of donation, were distributed.

2 units

CA

Red Blood Cells Leukocytes Reduced. Recall # B-0787-12

Unit: 084Q34442

The American National Red Cross, Oakland, CA, by letter on February 28, 2007. Firm initiated recall is complete.

Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.

1 unit

CA

Cornea. Recall # B-0789-12

Units: 071041ODC; 071041OSC

Minnesota Lions Eye Bank, Inc., Saint Paul, MN, by telephone on September 22, 2008 and letter dated September 30, 2008. Firm initiated recall is complete.

Human Corneas, with incomplete testing for relevant communicable disease agents, were distributed.

2 corneas

MN

1) Red Blood Cells. Recall # B-0803-12;

2) Cryoprecipitated AHF. Recall # B-0804-12

1) and 2) Unit: 8006695

Recalling Firm: New York Blood Center, Inc., New York, NY, by telephone on June 17, 2008.

Manufacturer: New York Blood Center, Inc., Westbury, NY. Firm initiated recall is complete.

Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.

2 units

NY, NJ, CA

1) Red Blood Cells Leukocytes Reduced. Recall # B-0812-12;

2) Red Blood Cells. Recall # B-0813-12;

3) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0814-12;

4) Plasma, Frozen within 24 hours (FP24). Recall # B-0815-12

1) Units: 017GW33723, 017GW33745, 017GW33749, 017GW33760, 017GW33771, 017GW33781, 017GW33786, 017GW33792, 017GW33813, 017GW33819, 017GW33831, 017GW33836, 017GW33849, 017GW33856, 017GW33872, 017GW33874, 017GW33877, 017GW33905, 017GW33999, 017LQ14406, 017LQ14269, 017LQ14312, 017LQ14314, 017LQ14342, 017LQ14192;

2) Unit: 17GW33755;

3) Units: 17GW33860, 17LQ14307;

4) Unit: 17GW33899

The American National Red Cross - North Central Region, Saint Paul, MN, by facsimile on April 3, 2009. Firm initiated recall is complete.

Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.

29 units

MN, WI, DC

Recovered Plasma Recall # B-0816-12

Units: W089209000891, 0266860, W089210003237

Sanford Medical Center (Blood Bank), Sioux Falls, SD, by facsimile on July 20, 2010. Firm initiated recall is complete.

Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.

3 units

FL

1) Red Blood Cells. Recall # B-0823-12;

2) Red Blood Cells for further manufacture. Recall # B-0824-12;

3) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0825-12;

4) Red Blood Cells Leukocytes Reduced. Recall # B-0826-12

1) Units: W039708032689A, W039709156570G, W039711538817S, W0397091795851, W039709197517U, W0397092028288, W039708045851G, W0397080494835, W039711538671W, W039711490219Z, W039711403152M, W039710377655S, W039710368588Y, W039709234504V, W0397103291921, W039708029091R, W039708031476F, W039708039549X, W039709162585Y;

2) Unit: W039711547145N;

3) Units: W039708034979W, W039709201175T;

4) Units: W039709220410S, W039709132475V, W039710293303T

Heartland Blood Centers, Aurora, IL, by telephone and facsimile on September 9, 2011 and by letter dated September 13, 2011. Firm initiated recall is complete.

Blood products, labeled with an extended expiration date, were distributed.

25 units

IL, LA, MI, MS. MO

Red Blood Cells Leukocytes Reduced. Recall # B-0830-12

Units: 21FV17566; 21FV17563; 21LH43096; 21LH43085; 21LJ38900; 21FV17565

American National Red Cross, Portland, OR, by telephone on January 15, 2007. Firm initiated recall is complete.

Blood products, in transit for more than 48 hours and possibly exposed to unacceptable shipping temperatures, were distributed.

6 units

WA

Red Blood Cells (Apheresis). Recall # B-0831-12

Unit: KY38078

San Diego Blood Bank, San Diego, CA, by letter dated May 27, 2008. Firm initiated recall is complete.

Blood product, which was not tested for hematocrit level, was distributed.

1 unit

CA

1) Red Blood Cells Leukocytes Reduced. Recall # B-0832-12;

2) Recovered Plasma Recall # B-0833-12

1) and 2) Unit: V53532

Delta Blood Bank, Stockton, CA, by facsimile or electronic notification on February 14, 2006. Firm initiated recall is complete.

Blood products, collected from a donor who had permanent make-up applied within 12 months of donation, were distributed.

2 units

CA, Austria

1) Red Blood Cells Leukocytes Reduced. Recall # B-0856-12;

2) Plasma Frozen. Recall # B-0857-12

1) Units: 06FR88140, 06LP14176;

2) Unit: 06FR88140

The American National Red Cross, Pomona, CA, by telephone or electronic notification on January 29, 2008 and by letter dated January 29, 2008. Firm initiated recall is complete.

Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.

3 units

CA

Platelets Pooled Leukocytes Reduced. Recall # B-0868-12

Unit: W356511002088

Community Blood Center of Carolinas, Charlotte, NC, by facsimile on March 15, 2011. Firm initiated recall is complete.

Blood product, collected from donor, whose suitability to donate was not adequately determined, was distributed.

1 unit

NC

Cornea Representative Labeling. Product was labeled in part: "***ID#: 2008-03-1665***CORNEA: OD***MEDIA: Optisol GS***AGE: 68***DEATH: 3-16-08@ 1805***PRESERVATION: 3-17-08 @ 0620***EXPIRES 14 DAYS FROM PRESERVATION / SINGLE PATIENT USE ONLY / NOT STERILE***Lions Eye Institute FOR TRANSPLANT & RESEARCH. ***” Recall # B-0879-12

Units: 2008031665, 2008031666

Lions Eye Institute for Transplant & Research, Inc., Tampa, FL, via fax and email on April 8, 2008. Firm initiated recall is complete.

Human Corneas, recovered from a donor with risk factors for relevant communicable disease agents, were distributed.

2 units

FL and Pakistan

Cornea: Representative labeling "***FLORIDA LIONS EYE *** FLEB# 11-***SINGLE PATIENT USE ONLY NOT STERILE STORE AT. Recall # B-0883-12

Unit: 1109076

Florida Lions Eye Bank, Inc., Miami, FL by letter dated October 20, 2011. Firm initiated recall is complete.

Human Cornea, recovered in a manner that may cause contamination or cross-contamination, was distributed.

1 unit

FL

 

Source Plasma. Recall # B-0351-12

Units: 07HWVA3063; 07HWVA3849; 07HWVA4158; 07HWVA4880; 07HWVA5127

Recalling Firm: BioLife Plasma Services L.P., Deerfield, Il, by fax on April 24, 2007.

Manufacturer: Bio Life Plasma Services, Huntington, WV. Firm initiated recall is complete.

Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.

5 units

CA

1) Cryoprecipitated AHF. Recall # B-0580-12;

2) Fresh Frozen Plasma. Recall # B-0581-12;

3) Fresh Frozen Plasma Apheresis. Recall # B-0582-12

1) Units: 221721484, 221722327, 221722329, 221722955, 221723333, 221724421, 221724502, 221724618, 221724938, 221725070, 221725078, 221725232, 221725318, 221725378, 221725434, 221725435, 221725893, 221725898, 221725902, 221726138, 221726144, 221726447, 221726458, 221727461, 221727529, 221727544, 221728665, 221728684, 221728751, 221728776;

 

2) Units: 182392703, 182392708, 182392829, 182393201, 182394015, 203116897, 203124396, 203130578, 203131920, 203131922, 203131923, 203131924, 203148419, 221098585, 221715352, 221716246, 221716251, 221716271, 221716440, 221716821, 221717669;

 

3) Unit: 182393474 (Part 2)

Blood Systems, Inc., Las Vegas, NV, by telephone on February 1, 2006. Firm initiated recall is complete.

Blood products, which may have reached an unacceptable temperature during shipment, were distributed.

52 units

CA

Recovered Plasma. Recall # B-0768-12

Unit: W036811294657

Community Blood Centers of Florida, Inc., Lauderhill, FL, by letter dated November 21, 2011. Firm initiated recall is complete.

Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.

1 unit

Switzerland

In-Vitro Diagnostics – Other. Recall # B-0783-12

Unit: 508825

Gen-Probe Inc., San Diego, CA, by e-mail, telephone or fax on September 15, 2006 and by letter on October 2, 2006. Firm initiated recall is complete.

Misbranded Procleix Auto Detect Reagent kits were distributed.

US: 321 units Outside US: 178 units

CA

Recovered Plasma. Recall # B-0788-12

Unit: 084Q34442

The American National Red Cross, Oakland, CA, by letter on February 28, 2007. Firm initiated recall is complete.

Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.

1 unit

CA

Source Plasma. Recall # B-0798-12

Units: 5140104479; 5140105293; 5140104222; 5140105056; 5140103561; 5140102721; 5140102477; 5140101907; 5140101649; 5140101109; 5140100861; 5140098109; 5140097510; 5140097194; 5140094804; 5140091357; 5140098426; 5140103296; 5140090694; 5140090123; 5140089528; 5140089204; 5140088542; 5140088205; 5140087387; 5140087051; 5140086334; 5140083023; 5140082600; 5140084818; 5140084282

Octapharma Plasma, Inc., Newport News, VA, by electronic mail on June 14, 2011. Firm initiated recall is complete.

Blood products, collected from a donor, for whom donor suitability was not adequately determined, were distributed.

31 units

Austria

Source Plasma. Recall # B-0799-12

Units: 3890168505; 3890167536; 3890166862; 3890166581; 3890165446; 3890163443; 3890162805; 3890162534; 3890162009; 3890161732; 3890161346; 3890161022; 3890160637; 3890157569; 3890156980; 3890155083; 3890153967; 3890150737; 3890149226; 3890148371

Recalling Firm: Octapharma Plasma, Inc., Charlotte, NC, by electronic mail on June 14, 2011.

Manufacturer: Octapharma Plasma, Inc., Lynchburg, VA. Firm initiated recall is complete.

Blood products, collected from a donor, for whom donor suitability was not adequately determined, were distributed.

20 units

Austria

Red Blood Cells Recall # B-0800-12

Units: 84GS75648, 84GS75649

The American National Red Cross, Oakland, CA, by letter dated July 3, 2008. Firm initiated recall is complete.

Blood products, collected using expired blood collection sets, were distributed.

2 units

CA

Platelets Pheresis Leukocytes Reduced. Recall # B-0801-12

Units: 04GZ04634 Part 1, 04GZ04634 Part 3

The American National Red Cross, Oakland CA, by telephone on July 24/2008. Firm initiated recall is complete.

Blood products, which did not meet shipping time frame, were distributed.

2 units

CA

Recovered Plasma Cryoprecipitate Reduced. Recall # B-0802-12

Unit: 8006695

Recalling Firm: New York Blood Center, Inc., New York, NY, by telephone on June 17, 2008.

Manufacturer: New York Blood Center, Inc., Westbury, NY. Firm initiated recall is complete.

Blood product, collected from donors, whose suitability to donate was not adequately determined, was distributed.

1 unit

NY, NJ, CA

1) Plasma Frozen. Recall # B-0805-12;

2) Red Blood Cells Leukocytes Reduced. Recall # B-0806-12;

3) Red Blood Cells, Leukocyte Reduced, CPDA-1. Recall # B-0807-12;

4) Red blood cells. Recall # B-0808-12

1) 20E76287, 20FH18219, 20FH18492, 20FH18502, 20FH18524, 20FH18961, 20FH19113, 20FT07933, 20FT08364, 20FW03828, 20FW12799, 20KK48569, 20KK49170, 20KK57650, 20KK59604, 20KS17025, 20KS17632, 20KS17653, 20KS18164, 20KS19773, 20KS21988, 20KS23479, 20KS25800, 20KS26676, 20KS26742, 20KS27208, 20KS27264, 20KS27992, 20KS28006, 20KS28011, 20KS29819, 20KS30626, 20KS30636, 20KV18990, 02KV23626, 20KV23987, 20KV26906, 20KV26909, 20KV27528, 20L36695, 20L39797, 20L41133, 20L41297, 20L41401, 20L41403, 20L42487, 20L42535, 20LE11902, 20LE14088, 20LE14136, 20LE14724, 20LE14740, 20LE14756, 20LE14983, 20LE14992, 20LE14996, 20LE15004, 20LE15019, 20LE15022, 20LE15028, 20LE15030, 20LE15473, 20LE15489, 20LE15522, 20LE15530, 20LF99349, 20LF99352, 20LG14908, 20LI15492, 20LK04050, 20LK04071, 20LK04092, 20LK04106, 20LK04193, 20LP77222, 20LP77327, 20LP77520, 20LP77522, 20LP77609, 20LP77613, 20LP77618, 20LP77638, 20LP77717, 20LP77751, 20LP77770, 20LP77774, 20LP77780, 20LP77785, 20LP77926, 20LP78049, 20LP78056, 20LP78256, 20LP78362, 20LP78779, 20LP78782, 20LP78834, 20LP79687, 20LP79699, 20LP79726, 20LP79728, 20LP79730, 20LP79849, 20LP80048, 20LP80065, 20LP80158, 20LP80168, 20LP80211, 20LP80215, 20LP80245, 20LP80528, 20LP80529, 20LP80806, 20LP80826, 20LP80851, 20LP80858, 20LP80861, 20LP80863, 20LP80866, 20LP80894, 20LP80999, 20LP81155, 20LP81293, 20LP81477, 20LP81478, 20LP81613, 20LP81789, 20LP81884, 20LP81970, 20LP81972, 20LP81996, 20LP82204, 20LP82208, 20LP82324, 20LP82407, 20LP82408, 20LP82436, 20LP82586, 20LP82592, 20LP82602, 20LP82734, 20LQ09971, 20LQ10905, 20LQ11122, 20LQ11250, 20LQ11274, 20LQ11275, 20LQ11301, 20LQ12238, 20LQ12242, 20LQ12253, 20LQ13359, 20LQ13666, 20LQ15257, 20LQ15267, 20LQ15400, 20LV07615, 20LV08192, 20LV08222, 20LV08234, 20LV08311, 20LV08356, 20M58429, 20M59415, 20M59745, 20W52877, 20W52884, 20W53051, 20X37951, 20X45007, 20X46125, 20X46708, 20X46732, 20X46992, 20Z39279, 20Z41057, 20Z41060, 20Z41783, 20Z41795;

 

2) Units: 20FH19111, 20FW12792, 20FW13015, 20KS31857, 20KV26906, 20KV26922, 20KV27063, 20KV27528, 20L42535, 20LE15955, 20LE16047, 20LP81789, 20LP81793, 20LP81811, 20LP81822, 20LP81875, 20LP81941, 20LP81944, 20LP81970, 20LP81972, 20LP81974, 20LP82216, 20LP82316, 20LP82407, 20LP82408, 20LP82483, 20LP82541, 20LP82550, 20LQ15321, 20LQ15390, 20LQ15400, 20LQ15409, 020LQ15472, 20X46708, 20X46992, 20Z41795, 20KS32039;

 

3) Unit: 20KS32039;

 

4) Units: 20FH18961, 20FH19113, 20FT08364, 20FW12799, 20FW13021, 20FW13042, 20KS31864, 20KV26909, 20KV26912, 20KV27411, 20KV27899, 20L42487, 20L42611, 20L42613, 20L42982, 20L42988, 20LE15834, 20LE15960, 20LE15965, 20LE16036, 20LE16050, 20LE16295, 20LP81864, 20LP81884, 20LP81928, 20LP81940, 20LP81947, 20LP82207, 20LP82208, 20LP82211, 20LP82277, 20LP82280, 20LP82284, 20LP82324, 20LP82347, 20LP82358, 20LP82371, 20LP82436, 20LP82472, 20LP82586, 20LP82592, 20LP82602, 20LP82734, 20LP82753, 20LP82755, 20LQ15257, 20LQ15267, 20LQ15278, 20LQ15298, 20LQ15308, 20LQ15328, 20LV07824, 20M59415, 20M59745, 20X46732, 20X46982, 20X46986, 20Z41057, 20Z41060

The American National Red Cross, Salt Lake City, UT, by facsimile on April 18, 2008. Firm initiated recall is complete.

Blood products, collected from donors with an invalid result for body temperature, were distributed,

275 units

CA, GA, ID, MA, MD, MT, MO, OK, OR, TN, UT, WY, and Puerto Rico

Central New York Eye and Tissue Bank Cornea preserved in Optisol GS. Recall # B-0809-12

Units: 090558OD, 090558OS

Recalling Firm: Upstate New York Transplant Services, Buffalo, NY, by letters dated March 3, 2010.

Manufacturer: Central New York Eye & Tissue Bank, Syracuse, NY. Firm initiated recall is complete.

Human corneas, recovered from a donor who was not adequately screened for risk factors for relevant communicable disease agents and diseases, were distributed.

2 corneas

CA and Mexico

Red Blood Cells Leukocytes Reduced, Recall # B-0834-12

Unit: J02854

Delta Blood Bank, Stockton, CA, by facsimile on February 13, 2006 and by letter dated March 31, 2006, Firm initiated recall is complete,

Blood product, collected from an ineligible donor, was distributed,

1 unit

CA

Recovered Plasma, Recall # B-0855-12

Unit: 06LP14176

The American National Red Cross, Pomona, CA, by telephone or electronic notification on January 29, 2008 and by letter dated January 29, 2008, Firm initiated recall is complete,

Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed,

1 unit

CA

Anti-Human Globulin (Rabbit/Murine Monoclonal) Product is labeled in part: "***Anti-Human Globulin***Anti-IgG (Rabbit)***Does not contain antibodies to complement components***5 x 20 CARDS***IVD***REF MTS084024***604206292". Recall # B-0884-12

Unit: 07121100101

Recalling Firm: Micro Typing Systems, Inc., Rochester, NY, by telephone on September 15, 2011.

Manufacturer: Micro Typing Systems, Inc., Pompano Beach, FL. Firm initiated recall is ongoing

Anti-Human Globulin Anti-IgG (Rabbit) MTS Anti-IgG Card, associated with false postive testing, was distributed.

7 units

PA

 

The V24-00400-29 cable is an accessory to the Newport HT50 ventilator intended to transfer the alarm signal from the ventilator to a nurse remote station. P/N V24-00400-90 Rev. B. Recall # Z-1041-2012

None

Flight Medical Ltd., Lod, Israel, by letter dated August 23, 2011. Firm initiated recall is ongoing.

A problem may occur when contact between an exposed unused wire and the grounding wire occurs. If this contact occurs the ventilator may reset and switch off.

363 units

Nationwide

Powerheart G3 Automated External Defibrillators (Non-Wearable) and include the following models: Powerheart 9300A, 9300E, 9300P, 9390A, 9390E; CardioVive 92532, 92533; Nihon-Kohden 9200G, 9231; and GE Responder 2019198, 2023440 AEDs. The Powerheart AED G3 is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. Post-resuscitation, if the victim is breathing, the AED should be left attached to allow for acquisition and detection of the ECG rhythm. If a shockable ventricular tachyarrhythmia recurs, the device will charge automatically and be able to deliver therapy. The device is intended to be used by personnel who have been trained. The user should be qualified by training in basic life support or other physician-authorized medical response. Recall # Z-1057-2012

Serial Numbers: 4372713, 4373884, 4373898, 4373902, 4373904, 4373906, 4373908, 4373913, 4373915, 4373917, 4373920, 4373922, 4373923, 4373925, 4373927, 4373931, 4373938, 4373944, 4373945, 4373946, 4373947, 4373949, 4373951, 4373952, 4373955, 4373956, 4373958, 4373959, 4373960, 4373965, 4373991, 4373993, 4373998, 4374002, 4374009, 4374010, 4374011, 4374012, 4374013, 4374014, 4374015, 4374018, 4374021, 4374023, 4374032, 4374035, 4374038, 4374050, 4374052, 4374053, 4374055, 4374056, 4374061, 4374065, 4374077, 4374082, 4374086, 4374096, 4374098, 4374102, 4374106, 4374110, 4374111, 4374115, 4374119, 4374137, 4374143, 4374151, 4374154, 4374159, 4374161, 4374165, 4374174, 4374175, 4374180, 4374181, 4374182, 4374183, 4374186, 4374188, 4374191, 4374193, 4374196, 4374203, 4374204, 4374209, 4374210, 4374212, 4374215, 4374220, 4374230, 4374235, 4374240, 4374244, 4374257, 4374275, 4374283, 4374285, 4374286, 4374288, 4374294, 4374297, 4374299, 4374368, 4374369, 4374370, 4374372, 4374375, 4374377, 4374378, 4374380, 4374389, 4374390, 4374394, 4374396, 4374399, 4374427, 4374428, 4374429, 4374431, 4374435, 4374440, 4374442, 4374446, 4374454, 4374459, 4374463, 4374465, 4374487, 4374488, 4374491, 4374493, 4374495, 4374497, 4374504, 4374506, 4374508, 4374509, 4374511, 4374515, 4374516, 4374519, 4374520, 4374522, 4374529, 4374530, 4374539, 4374542, 4374544, 4374546, 4374547, 4374548, 4374549, 4374550, 4374551, 4374552, 4374554, 4374555, 4374559, 4374560, 4374562, 4374564, 4374571, 4374575, 4374578, 4374579, 4374590, 4374597, 4374599, 4374600, 4374601, 4374602, 4374604, 4374607, 4374612, 4374614, 4374618, 4374619, 4374620, 4374622, 4374623, 4374626, 4374627, 4374628, 4374630, 4374636, 4374660, 4374663, 4374671, 4374677, 4374678, 4374683, 4374698, 4374701, 4374703, 4374705, 4374714, 4374717, 4374719, 4374721, 4374722, 4374723, 4374724, 4374725, 4374728, 4374731, 4374733, 4374735, 4374740, 4374742, 4374745, 4374758, 4374761, 4374762, 4374774, 4374775, 4374785, 4374787, 4374796, 4374801, 4374802, 4374805, 4374806, 4374813, 4374816, 4374819, 4374820, 4374821, 4374822, 4374836, 4375055, 4375059, 4375061, 4375066, 4375107, 4375112, 4375114, 4375118, 4375122, 4375125, 4375128, 4375129, 4375131, 4375134, 4375136, 4375180, 4375184, 4375187, 4375659, 4375679, 4376016, 4376018, 4376019, 4376020, 4376021, 4376022, 4376023, 4376024, 4376025, 4376026, 4376027, 4376028, 4376029, 4376030, 4376031, 4376032, 4376033, 4376034, 4376035, 4376036, 4376037, 4376038, 4376039, 4376040, 4376041, 4376042, 4376043, 4376044, 4376045, 4376046, 4376047, 4376048, 4376049, 4376050, 4376051, 4376052, 4376053, 4376054, 4376055, 4376056, 4376057, 4376058, 4376059, 4376060, 4376061, 4376062, 4376064, 4376065, 4376066, 4376067, 4376068, 4376070, 4376071, 4376072, 4376073, 4376075, 4376077, 4376078, 4376079, 4376080, 4376081, 4376082, 4376083, 4376084, 4376085, 4376086, 4376087, 4376088, 4376089, 4376090, 4376091, 4376092, 4376093, 4376094, 4376095, 4376096, 4376097, 4376100, 4376101, 4376102, 4376103, 4376104, 4376105, 4376107, 4376110, 4376111, 4376113, 4376114, 4376115, 4376117, 4376118, 4376119, 4376120, 4376121, 4376122, 4376123, 4376124, 4376125, 4376126, 4376127, 4376128, 4376129, 4376130, 4376132, 4376136, 4376138, 4376139, 4376140, 4376142, 4376143, 4376144, 4376145, 4376146, 4376147, 4376149, 4376150, 4376151, 4376152, 4376153, 4376154, 4376155, 4376156, 4376157, 4376158, 4376159, 4376160, 4376162, 4376163, 4376164, 4376166, 4376168, 4376169, 4376171, 4376173, 4376175, 4376176, 4376179, 4376180, 4376181, 4376183, 4376184, 4376185, 4376187, 4376188, 4376191, 4376193, 4376197, 4376198, 4376200, 4376201, 4376202, 4376205, 4376206, 4376208, 4376209, 4376210, 4376211, 4376212, 4376214, 4376216, 4376217, 4376218, 4376219, 4376220, 4376224, 4376227, 4376244, 4376247, 4376248, 4376251, 4376252, 4376253, 4376254, 4376255, 4376256, 4376257, 4376258, 4376259, 4376260, 4376261, 4376262, 4376263, 4376264, 4376265, 4376266, 4376268, 4376269, 4376271, 4376273, 4376276, 4376278, 4376279, 4376280, 4376281, 4376282, 4376285, 4376291, 4376294, 4376295, 4376296, 4376297, 4376298, 4376299, 4376300, 4376301, 4376302, 4376303, 4376304, 4376305, 4376306, 4376307, 4376308, 4376311, 4376312, 4376313, 4376315, 4376316, 4376317, 4376318, 4376319, 4376320, 4376321, 4376322, 4376323, 4376325, 4376326, 4376328, 4376329, 4376331, 4376332, 4376333, 4376334, 4376335, 4376336, 4376337, 4376338, 4376339, 4376340, 4376341, 4376342, 4376343, 4376344, 4376345, 4376346, 4376347, 4376348, 4376349, 4376351, 4376352, 4376353, 4376354, 4376355, 4376356, 4376357, 4376358, 4376359, 4376360, 4376361, 4376362, 4376363, 4376364, 4376365, 4376366, 4376367, 4376368, 4376369, 4376370, 4376371, 4376372, 4376373, 4376374, 4376375, 4376376, 4376377, 4376378, 4376379, 4376380, 4376381, 4376382, 4376383, 4376384, 4376385, 4376386, 4376387, 4376388, 4376389, 4376390, 4376391, 4376392, 4376393, 4376394, 4376395, 4376396, 4376397, 4376398, 4376399, 4376404, 4376405, 4376406, 4376407, 4376408, 4376409, 4376410, 4376411, 4376412, 4376413, 4376414, 4376415, 4376416, 4376417, 4376418, 4376419, 4376420, 4376421, 4376425, 4376426, 4376427, 4376428, 4376429, 4376430, 4376431, 4376432, 4376433, 4376436, 4376438, 4376440, 4376442, 4376444, 4376445, 4376447, 4376448, 4376450, 4376451, 4376452, 4376453, 4376455, 4376456, 4376457, 4376460, 4376463, 4376464, 4376465, 4376466, 4376467, 4376468, 4376469, 4376470, 4376471, 4376472, 4376474, 4376475, 4376476, 4376477, 4376478, 4376479, 4376480, 4376482, 4376483, 4376484, 4376485, 4376486, 4376487, 4376488, 4376489, 4376490, 4376491, 4376492, 4376495, 4376496, 4376498, 4376505, 4376507, 4376509, 4376511, 4376512, 4376513, 4376514, 4376515, 4376516, 4376517, 4376518, 4376520, 4376521, 4376522, 4376523, 4376524, 4376525, 4376527, 4376528, 4376529, 4376530, 4376531, 4376533, 4376534, 4376535, 4376537, 4376538, 4376539, 4376540, 4376542, 4376544, 4376545, 4376546, 4376547, 4376548, 4376549, 4376550, 4376551, 4376552, 4376553, 4376554, 4376555, 4376556, 4376557, 4376558, 4376559, 4376561, 4376563, 4376565, 4376566, 4376567, 4376568, 4376569, 4376845, 4376846, 4376847, 4376848, 4376849, 4376850, 4376851, 4376852, 4376853, 4376854, 4376855, 4376856, 4376857, 4376858, 4376861, 4377088, 4377095, 4377096, 4377097, 4377098, 4377099, 4377100, 4377101, 4377102, 4377103, 4377104, 4377105, 4377106, 4377107, 4377108, 4377109, 4377110, 4377111, 4377112, 4377113, 4377114, 4377115, 4377116, 4377117, 4377118, 4377119, 4377120, 4377122, 4377123, 4377124, 4377125, 4377126, 4377129, 4377130, 4377131, 4377132, 4377133, 4377134, 4377135, 4377137, 4377138, 4377139, 4377140, 4377141, 4377142, 4377143, 4377144, 4377145, 4377146, 4377147, 4377148, 4377149, 4377150, 4377151, 4377152, 4377153, 4377154, 4377155, 4377156, 4377157, 4377158, 4377159, 4377160, 4377161, 4377162, 4377163, 4377164, 4377165, 4377166, 4377167, 4377168, 4377169, 4377170, 4377171, 4377172, 4377173, 4377174, 4377175, 4377176, 4377177, 4377178, 4377179, 4377180, 4377181, 4377182, 4377183, 4377184, 4377185, 4377186, 4377187, 4377188, 4377189, 4377190, 4377191, 4377192, 4377193, 4377194, 4377195, 4377196, 4377197, 4377198, 4377199, 4377200, 4377201, 4377202, 4377204, 4377222, 4377224, 4377225, 4377226, 4377227, 4377228, 4377229, 4377230, 4377231, 4377232, 4377233, 4377234, 4377235, 4377236, 4377237, 4377238, 4377239, 4377240, 4377241, 4377242, 4377243, 4377244, 4377245, 4377246, 4377247, 4377248, 4377249, 4377250, 4377251, 4377252, 4377253, 4377254, 4377255, 4377256, 4377257, 4377258, 4377259, 4377260, 4377261, 4377262, 4377263, 4377264, 4377265, 4377266, 4377267, 4377268, 4377269, 4377270, 4377271, 4377272, 4377273, 4377274, 4377275, 4377276, 4377277, 4377305, 4377306, 4377307, 4377308, 4377309, 4377311, 4377312, 4377313, 4377314, 4377315, 4377316, 4377317, 4377318, 4377319, 4377320, 4377321, 4377322, 4377323, 4377324, 4377325, 4377326, 4377327, 4377328, 4377329, 4377330, 4377331, 4377332, 4377333, 4377334, 4377335, 4377336, 4377337, 4377338, 4377339, 4377340, 4377341, 4377342, 4377343, 4377344, 4377345, 4377346, 4377347, 4377348, 4377349, 4377350, 4377351, 4377352, 4377353, 4377354, 4377355, 4377356, 4377358, 4377359, 4377360, 4377361, 4377362, 4377363, 4377364, 4377365, 4377366, 4377367, 4377368, 4377370, 4377372, 4377373, 4377374, 4377375, 4377376, 4377377, 4377378, 4377379, 4377380, 4377381, 4377382, 4377383, 4377384, 4377385, 4377386, 4377387, 4377388, 4377389, 4377390, 4377391, 4377392, 4377393, 4377394, 4377395, 4377396, 4377397, 4377398, 4377399, 4377400, 4377401, 4377402, 4377403, 4377404, 4377405, 4377406, 4377407, 4377408, 4377409, 4377410, 4377411, 4377412, 4377413, 4377414, 4377415, 4377416, 4377417, 4377418, 4377419, 4377420, 4377421, 4377422, 4377423, 4377424, 4377425, 4377426, 4377427, 4377428, 4377429, 4377430, 4377431, 4377432, 4377433, 4377434, 4377435, 4377436, 4377437, 4377438, 4377439, 4377440, 4377441, 4377442, 4377443, 4377444, 4377445, 4377446, 4377447, 4377448, 4377449, 4377450, 4377451, 4377452, 4377453, 4377454, 4377455, 4377456, 4377457, 4377458, 4377459, 4377460, 4377461, 4377462, 4377463, 4377464, 4377465, 4377466, 4377467, 4377468, 4377469, 4377470, 4377471, 4377472, 4377473, 4377474, 4377475, 4377476, 4377477, 4377478, 4377479, 4377480, 4377481, 4377482, 4377483, 4377484, 4377485, 4377486, 4377487, 4377488, 4377489, 4377490, 4377491, 4377492, 4377493, 4377494, 4377495, 4377496, 4377497, 4377498, 4377499, 4377500, 4377501, 4377502, 4377503, 4377504, 4377505, 4377506, 4377507, 4377508, 4377509, 4377510, 4377511, 4377512, 4377513, 4377514, 4377515, 4377516, 4377517, 4377518, 4377519, 4377520, 4377521, 4377522, 4377523, 4377524, 4377525, 4377526, 4377527, 4377542, 4377543, 4377544, 4377545, 4377547, 4377549, 4377550, 4377551, 4377552, 4377553, 4377578, 4377579, 4377580, 4377581, 4377583, 4377584, 4377596, 4377598, 4377599, 4377600, 4377601, 4377602, 4377603, 4377604, 4377605, 4377606, 4377607, 4377608, 4377609, 4377610, 4377611, 4377612, 4377613, 4377614, 4377615, 4377616, 4377617, 4377618, 4377619, 4377620, 4377621, 4377622, 4377623, 4377624, 4377625, 4377626, 4377627, 4377628, 4377629, 4377631, 4377632, 4377633, 4377634, 4377635, 4377636, 4377637, 4377638, 4377639, 4377640, 4377641, 4377642, 4377643, 4377644, 4377645, 4377646, 4377647, 4377648, 4377649, 4377650, 4377651, 4377652, 4377653, 4377654, 4377655, 4377656, 4377657, 4377658, 4377659, 4377660, 4377661, 4377662, 4377663, 4377664, 4377665, 4377666, 4377667, 4377668, 4377670, 4377671, 4377672, 4377673, 4377674, 4377675, 4377676, 4377677, 4377678, 4377679, 4377680, 4377681, 4377682, 4377683, 4377684, 4377685, 4377686, 4377687, 4377688, 4377690, 4377691, 4377692, 4377693, 4377694, 4377695, 4377696, 4377697, 4377698, 4377699, 4377700, 4377701, 4377702, 4377703, 4377704, 4377705, 4377706, 4377707, 4377708, 4377709, 4377710, 4377711, 4377712, 4377713, 4377714, 4377715, 4377716, 4377717, 4377718, 4377719, 4377720, 4377721, 4377722, 4377723, 4377724, 4377725, 4377726, 4377727, 4377728, 4377729, 4377730, 4377731, 4377732, 4377733, 4377734, 4377735, 4377736, 4377738, 4377739, 4377740, 4377741, 4377742, 4377743, 4377744, 4377745, 4377746, 4377747, 4377748, 4377749, 4377750, 4377751, 4377752, 4377753, 4377754, 4377755, 4377756, 4377757, 4377758, 4377759, 4377760, 4377761, 4377762, 4377763, 4377765, 4377766, 4377767, 4377768, 4377769, 4377770, 4377771, 4377772, 4377773, 4377774, 4377775, 4377776, 4377777, 4377778, 4377779, 4377780, 4377781, 4377782, 4377783, 4377784, 4377785, 4377786, 4377787, 4377788, 4377789, 4377790, 4377791, 4377792, 4377793, 4377794, 4377795, 4377796, 4377797, 4377798, 4377799, 4377800, 4377801, 4377802, 4377803, 4377804, 4377805, 4377806, 4377807, 4377808, 4377809, 4377810, 4377811, 4377812, 4377813, 4377814, 4377815, 4377816, 4377817, 4377818, 4377819, 4377820, 4377821, 4377822, 4377824, 4377826, 4377827, 4377828, 4377829, 4377830, 4377831, 4377832, 4377833, 4377834, 4377835, 4377836, 4377837, 4377838, 4377839, 4377840, 4377841, 4377842, 4377843, 4377844, 4377845, 4377846, 4377847, 4377848, 4377849, 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4389506, 4389507, 4389508, 4389509, 4389510, 4389511, 4389512, 4389513, 4389514, 4389515, 4389516, 4389517, 4389518, 4389519, 4389520, 4389521, 4389522, 4389523, 4389524, 4389525, 4389526, 4389527, 4389528, 4389529, 4389530, 4389531, 4389532, 4389533, 4389534, 4389535, 4389536, 4389537, 4389538, 4389539, 4389540, 4389541, 4389542, 4389543, 4389544, 4389545, 4389546, 4389547, 4389548, 4389549, 4389600, 4389601, 4389602, 4389603, 4389604, 4389605, 4389606, 4389607, 4389608, 4389609, 4389610, 4389611, 4389613, 4389614, 4389615, 4389616, 4389625, 4389626, 4389627, 4389628, 4389629, 4389630, 4389631, 4389632, 4389633, 4389634, 4389639, 4389640, 4389641, 4389642, 4389643, 4389644, 4389645, 4389646, 4389647, 4389648, 4389649, 4389650, 4389651, 4389652, 4389653, 4389654, 4389655, 4389656, 4389657, 4389658, 4389659, 4389660, 4389661, 4389662, 4389663, 4389664, 4389665, 4389666, 4389667, 4389668, 4389669, 4389670, 4389671, 4389672, 4389673, 4389674, 4389675, 4389676, 4389677, 4389678, 4389679, 4389680, 4389681, 4389682, 4389683, 4389684, 4389685, 4389686, 4389687, 4389688, 4389689, 4389690, 4389691, 4389692, 4389693, 4389694, 4389695, 4389696, 4389697, 4389698, 4389699, 4389700, 4389701, 4389702, 4389703, 4389704, 4389705, 4389706, 4389707, 4389708, 4389709, 4389710, 4389711, 4389712, 4389713, 4389714, 4389715, 4389716, 4389717, 4389718, 4389719, 4389720, 4389721, 4389722, 4389723, 4389724, 4389725, 4389726, 4389727, 4389728, 4389729, 4389730, 4389731, 4389732, 4389733, 4389734, 4389735, 4389736, 4389737, 4389738, 4389739, 4389740, 4389741, 4389742, 4389743, 4389744, 4389745, 4389746, 4389747, 4389748, 4389749, 4389750, 4389751, 4389752, 4389753, 4389754, 4389755, 4389756, 4389757, 4389758, 4389759, 4389760, 4389761, 4389762, 4389763, 4389764, 4389765, 4389766, 4389767, 4389768, 4389769, 4389770, 4389771, 4389772, 4389773, 4389774, 4389775, 4389776, 4389777, 4389778, 4389779, 4389780, 4389781, 4389782, 4389783, 4389784, 4389785, 4389786, 4389787, 4389788, 4389789, 4389790, 4389791, 4389792, 4389793, 4389794, 4389795, 4389796, 4389797, 4389798, 4389799, 4389800, 4389801, 4389802, 4389803, 4389804, 4389805, 4389806, 4389807, 4389808, 4389809, 4389810, 4389811, 4389812, 4389813, 4389814, 4389815, 4389816, 4389817, 4389818, 4389819, 4389820, 4389821, 4389822, 4389823, 4389824, 4389825, 4389826, 4389827, 4389828, 4389829, 4389830, 4389831, 4389832, 4389834, 4389839, 4389842, 4389846, 4389847, 4389848, 4389849, 4389851, 4389852, 4389853, 4389854, 4389855, 4389856, 4389857, 4389858, 4389859, 4389860, 4389861, 4389862, 4389863, 4389864, 4389865, 4389866, 4389867, 4389868, 4389869, 4389870, 4389871, 4389879, 4389881, 4389886, 4389887, 4389888, 4389889, 4389890, 4389891, 4389892, 4389893, 4389894, 4389895, 4389896, 4389897, 4389898, 4389899, 4389900, 4389901, 4389902, 4389903, 4389904, 4389905, 4389906, 4389907, 4389908, 4389909, 4389910, 4389911, 4389912, 4389914, 4389915, 4389916, 4389917, 4389918, 4389919, 4389920, 4389923, 4389927, 4389930, 4389932, 4389933, 4389934, 4389935, 4389937, 4389938, 4389944, 4389945, 4389947, 4389949, 4389950, 4389951, 4389952, 4389953, 4389954, 4389955, 4389956, 4389957, 4389958, 4389959, 4389960, 4389962, 4389963, 4389964, 4389965, 4389968, 4389970, 4389971, 4389972, 4389973, 4389974, 4389975, 4389976, 4389977, 4389978, 4389979, 4389980, 4389981, 4389982, 4389983, 4389984, 4389985, 4389986, 4389987, 4389988, 4389990, 4389992, 4389993, 4389995, 4389996, 4389997, 4389999, 4390000, 4390001, 4390002, 4390003, 4390005, 4390006, 4390007, 4390009, 4390010, 4390011, 4390012, 4390013, 4390014, 4390015, 4390016, 4390018, 4390019, 4390020, 4390021, 4390022, 4390023, 4390024, 4390025, 4390026, 4390027, 4390028, 4390029, 4390030, 4390031, 4390032, 4390033, 4390034, 4390035, 4390036, 4390037, 4390038, 4390039, 4390040, 4390041, 4390042, 4390043, 4390044, 4390045, 4390046, 4390047, 4390048, 4390049, 4390050, 4390051, 4390052, 4390053, 4390054, 4390055, 4390056, 4390057, 4390058, 4390059, 4390060, 4390061, 4390100, 4390101, 4390102, 4390103, 4390104, 4390105, 4390106, 4390107, 4390108, 4390109, 4390110, 4390111, 4390112, 4390113, 4390114, 4390115, 4390116, 4390117, 4390118, 4390119, 4390120, 4390121, 4390122, 4390123, 4390124, 4390125, 4390126, 4390127, 4390128, 4390129, 4390130, 4390131, 4390132, 4390133, 4390134, 4390135, 4390136, 4390137, 4390138, 4390139, 4390140, 4390141, 4390143, 4390144, 4390145, 4390146, 4390147, 4390148, 4390149, 4390150, 4390151, 4390152, 4390153, 4390154, 4390155, 4390156, 4390157, 4390158, 4390159, 4390160, 4390161, 4390162, 4390163, 4390164, 4390165, 4390166, 4390167, 4390168, 4390169, 4390170, 4390171, 4390172, 4390173, 4390174, 4390175, 4390176, 4390177, 4390178, 4390179, 4390180, 4390181, 4390182, 4390183, 4390184, 4390185, 4390186, 4390187, 4390188, 4390189, 4390192, 4390201, 4390204, 4390223, 4390225, 4390254, 4390274, 4390276, 4390278, 4390279, 4390283, 4390284, 4390285, 4390289, 4390339, 4390340, 4390341, 4390342, 4390345, 4390346, 4390347, 4390348, 4390353, 4390355, 4390356, 4390357, 4390360, 4390373, 4390375, 4390376, 4390377, 4390381, 4390382, 4390383, 4390385, 4390386, 4390388, 4390390, 4390392, 4390394, 4390395, 4390396, 4390397, 4390398, 4390399, 4390400, 4390436, 4390438, 4390442, 4390452, 4390495, 4390499, 4390500, 4390504, 4390505, 4390508, 4390509, 4390510, 4390511, 4390512, 4390513, 4390514, 4390515, 4390570, 4390571, 4390573, 4390574, 4390576, 4390577, 4390578, 4390579, 4390580, 4390581, 4390582, 4390583, 4390595, 4390605, 4390617, 4390618, 4390619, 4390620, 4390621, 4390623, 4390625, 4390633, 4390636, 4390637, 4390638, 4390640, 4390641, 4390645, 4390647, 4390648, 4390649, 4390650, 4390651, 4390652, 4390655, 4390657, 4390665, 4390666, 4390667, 4390674, 4390675, 4390686, 4390687, 4390691, 4390693, 4390694, 4390696, 4390697, 4390699, 4390700, 4390702, 4390705, 4390706, 4390707, 4390709, 4390712, 4390713, 4390715, 4390754, 4390762, 4390790, 4390792, 4390793, 4390794, 4390795, 4390798, 4390799, 4390800, 4390801, 4390803, 4390804, 4390805, 4390806, 4390807, 4390808, 4390809, 4390810, 4390811, 4390812, 4390813, 4390814, 4390815, 4390816, 4390817, 4390818, 4390819, 4390820, 4390821, 4390822, 4390823, 4390824, 4390825, 4390826, 4390827, 4390828, 4390829, 4390830, 4390831, 4390832, 4390833, 4390834, 4390835, 4390836, 4390837, 4390838, 4390839, 4390840, 4390841, 4390842, 4390843, 4390844, 4390845, 4390846, 4390847, 4390848, 4390849, 4390850, 4390852, 4390853, 4390854, 4390856, 4390857, 4390858, 4390859, 4390860, 4390862, 4390863, 4390866, 4390867, 4390868, 4390871, 4390873, 4390877, 4390878, 4390880, 4390882, 4390883, 4390884, 4390885, 4390886, 4390889, 4390890, 4390892, 4390895, 4390896, 4390898, 4390900, 4390901, 4390902, 4390903, 4390904, 4390906, 4390907, 4390909, 4390911, 4390912, 4390914, 4390915, 4390916, 4390917, 4390918, 4390919, 4390921, 4390922, 4390923, 4390924, 4390925, 4390926, 4390927, 4390928, 4390932, 4390933, 4390935, 4390938, 4390939, 4390940, 4390941, 4390942, 4390943, 4390944, 4390945, 4390947, 4390950, 4390954, 4390956, 4390959, 4390960, 4390961, 4390962, 4390963, 4390968, 4390969, 4390970, 4390971, 4390972, 4390973, 4390974, 4390975, 4390976, 4390977, 4390978, 4390979, 4390981, 4390982, 4390984, 4390985, 4390986, 4390987, 4390989, 4390990, 4390991, 4390992, 4390993, 4391194, and 4391195

Cardiac Science Corp., Bothell, WA, by letter dated January 13, 2012, followed by telephone or e-mail. Firm initiated recall is ongoing.

The affected Automated External Defibrillators (AEDs) contains a circuit board manufactured with a component that may fail unexpectedly due to a supplier manufacturing defect. If the component were to fail during a rescue attempt, the AED may not deliver defibrillation therapy.

11,019 units (6142 units Nationwide; and 4877 units internationally)

Nationwide and Internationally

Inspira AIR Balloon Dilation System, size 18 x 40; Product Usage: Dilation of airway tree. Product code BC1840A, Size 18 x 40. Recall # Z-1095-2012

Lot 110307E, Exp 3/2013; Lot 110429E, Exp 4/2013; Lot 110502B, Exp 5/2013; Lot 110506B, Exp 5/2013; Lot 110606B, Exp 6/2013; Lot 110614B, Exp 6/2013

Acclarent, Inc., Menlo Park, CA, by letter dated January 31, 2012. Firm initiated recall is ongoing.

Acclarent received reports of difficulty deflating the balloon during the procedure, which could potentially result in airway obstruction.

633 units

Nationwide

 

Spectra Optia Apheresis System, REF: 61000. A blood component separator used for therapeutic plasma exchanges. Recall # Z-0191-2012

Serial Numbers: 1P00100 - 1P00XXX

Caridian BCT, Inc., Lakewood, CO, by letter dated September 2011, and November 2011. Firm initiated recall is ongoing.

Possible higher than expected platelet loss following therapeutic plasma exchange or plasmapheresis.

852 units

Nationwide and Internationally

Ambulatory Blood Pressure (ABP) Monitor, Model 90217A. The Spacelabs Model 90217A Ambulatory Blood Pressure (ABP) Monitor is a small, lightweight unit designed to take blood pressure and heart rate measurements for a 24 hour, 48 hour, or longer period. Recall # Z-0304-2012

Serial Numbers: 217A-000001, 217A-000013, 217A-000017, 217A-000018, 217A-000019, 217A-000020, 217A-000021, 217A-000022, 217A-000026, 217A-000027, 217A-000028, 217A-000029, 217A-000032, 217A-000033, 217A-000034, 217A-000035, 217A-000036, 217A-000037, 217A-000038, 217A-000039, 217A-000040, 217A-000041, 217A-000042, 217A-000043, 217A-000044, 217A-000045, 217A-000046, 217A-000047, 217A-000048, 217A-000049, 217A-000050, 217A-000051, 217A-000052, 217A-000055, 217A-000056, 217A-000057, 217A-000058, 217A-000059, 217A-000060, 217A-000066, 217A-000068, 217A-000069, 217A-000070, 217A-000071, 217A-000072, 217A-000073, 217A-000074, 217A-000075, 217A-000076, 217A-000077, 217A-000078, 217A-000079, 217A-000080, 217A-000081, 217A-000082, 217A-000083, 217A-000084, 217A-000085, 217A-000086, 217A-000087, 217A-000088, 217A-000089, 217A-000090, 217A-000091, 217A-000092, 217A-000093, 217A-000094, 217A-000095, 217A-000096, 217A-000103, 217A-000104, 217A-000105, 217A-000106, 217A-000107, 217A-000108, 217A-000109, 217A-000110, 217A-000111, 217A-000112, 217A-000113, 217A-000114, 217A-000115, 217A-000116, 217A-000117, 217A-000118, 217A-000119, 217A-000120, 217A-000121, 217A-000122, 217A-000123, 217A-000124, 217A-000125, 217A-000126, 217A-000127, 217A-000128, 217A-000129, 217A-000130, 217A-000131, 217A-000132, 217A-000133, 217A-000134, 217A-000135, 217A-000136, 217A-000137, 217A-000138, 217A-000139, 217A-000140, 217A-000141, 217A-000142, 217A-000143, 217A-000144, 217A-000145, 217A-000146, 217A-000147, 217A-000148, 217A-000149, 217A-000150, 217A-000151, 217A-000152, 217A-000153, 217A-000154, 217A-000155, 217A-000156, 217A-000157, 217A-000158, 217A-000159, 217A-000160, 217A-000161, 217A-000162, 217A-000163, 217A-000164, 217A-000165, 217A-000166, 217A-000167, 217A-000168, 217A-000169, 217A-000170, 217A-000171, 217A-000172, 217A-000173, 217A-000174, 217A-000175, 217A-000176, 217A-000177, 217A-000178, 217A-000179, 217A-000180, 217A-000181, 217A-000182, 217A-000183, 217A-000184, 217A-000185, 217A-000186, 217A-000187, 217A-000188, 217A-000189, 217A-000190, 217A-000191, 217A-000192, 217A-000193, 217A-000194, 217A-000195, 217A-000196, 217A-000197, 217A-000198, 217A-000199, 217A-000200, 217A-000201, 217A-000202, 217A-000203, 217A-000204, 217A-000205, 217A-000207, 217A-000208, 217A-000209, 217A-000210, 217A-000211, 217A-000212, 217A-000213, 217A-000214, 217A-000215, 217A-000216, 217A-000217, 217A-000218, 217A-000219, 217A-000220, 217A-000221, 217A-000222, 217A-000223, 217A-000224, 217A-000225, 217A-000226, 217A-000227, 217A-000228, 217A-000229, 217A-000230, 217A-000231, 217A-000232, 217A-000233, 217A-000234, 217A-000235, 217A-000236, 217A-000237, 217A-000238, 217A-000239, 217A-000240, 217A-000241, 217A-000242, 217A-000243, 217A-000244, 217A-000245, 217A-000246, 217A-000247, 217A-000248, 217A-000249, 217A-000250, 217A-000251, 217A-000252, 217A-000253, 217A-000254, 217A-000255, 217A-000256, 217A-000257, 217A-000258, 217A-000259, 217A-000260, 217A-000261, 217A-000262, 217A-000263, 217A-000264, 217A-000265, 217A-000266, 217A-000267, 217A-000268, 217A-000269, 217A-000270, 217A-000271, 217A-000272, 217A-000273, 217A-000274, 217A-000275, 217A-000276, 217A-000277, 217A-000278, 217A-000279, 217A-000280, 217A-000281, 217A-000282, 217A-000283, 217A-000284, 217A-000285, 217A-000286, 217A-000287, 217A-000288, 217A-000289, 217A-000290, 217A-000291, 217A-000292, 217A-000293, 217A-000294, 217A-000295, 217A-000296, 217A-000297, 217A-000298, 217A-000299, 217A-000300, 217A-000301, 217A-000302, 217A-000303, 217A-000304, 217A-000305, 217A-000306, 217A-000307, 217A-000308, 217A-000309, 217A-000310, 217A-000311, 217A-000312, 217A-000313, 217A-000314, 217A-000315, 217A-000316, 217A-000317, 217A-000318, 217A-000319, 217A-000320, 217A-000321, 217A-000322, 217A-000323, 217A-000324, 217A-000325, 217A-000326, 217A-000327, 217A-000328, 217A-000329, 217A-000330, 217A-000331, 217A-000332, 217A-000333, 217A-000334, 217A-000335, 217A-000336, 217A-000337, 217A-000338, 217A-000339, 217A-000340, 217A-000341, 217A-000343, 217A-000344, 217A-000345, 217A-000346, 217A-000347, 217A-000348, 217A-000349, 217A-000350, 217A-000351, 217A-000352, 217A-000353, 217A-000354, 217A-000355, 217A-000356, 217A-000357, 217A-000358, 217A-000359, 217A-000360, 217A-000361, 217A-000362, 217A-000363, 217A-000364, 217A-000365, 217A-000366, 217A-000367, 217A-000368, 217A-000369, 217A-000370, 217A-000371, 217A-000372, 217A-000373, 217A-000374, 217A-000375, 217A-000376, 217A-000377, 217A-000378, 217A-000379, 217A-000380, 217A-000381, 217A-000382, 217A-000383, 217A-000384, 217A-000385, 217A-000386, 217A-000387, 217A-000388, 217A-000389, 217A-000390, 217A-000391, 217A-000392, 217A-000393, 217A-000394, 217A-000395, 217A-000396, 217A-000397, 217A-000398, 217A-000399, 217A-000400, 217A-000401, 217A-000402, 217A-000403, 217A-000404, 217A-000405, 217A-000406, 217A-000407, 217A-000408, 217A-000409, 217A-000410, 217A-000411, 217A-000412, 217A-000413, 217A-000414, 217A-000415, 217A-000416, 217A-000417, 217A-000418, 217A-000419, 217A-000421, 217A-000422, 217A-000423, 217A-000424, 217A-000425, 217A-000427, 217A-000428, 217A-000430, 217A-000431, 217A-000433, 217A-000435, 217A-000437, 217A-000438, 217A-000439, 217A-000440, 217A-000441, 217A-000442, 217A-000443, 217A-000444, 217A-000446, 217A-000447, 217A-000448, 217A-000449, 217A-000450, 217A-000452, 217A-000453, 217A-000454, 217A-000455, 217A-000456, 217A-000457, 217A-000458, 217A-000459, 217A-000460, 217A-000461, 217A-000465, 217A-000467, 217A-000469, 217A-000470, 217A-000471, 217A-000472, 217A-000473, 217A-000474, 217A-000475, 217A-000476, 217A-000477, 217A-000478, 217A-000480, 217A-000481, 217A-000482, 217A-000484, 217A-000485, 217A-000486, 217A-000487, 217A-000488, 217A-000489, 217A-000490, 217A-000491, 217A-000492, 217A-000493, 217A-000494, 217A-000495, 217A-000496, 217A-000498, 217A-000499, 217A-000500, 217A-000501, 217A-000502, 217A-000503, 217A-000505, 217A-000506, 217A-000507, 217A-000508, 217A-000509, 217A-000510, 217A-000511, 217A-000512, 217A-000513, 217A-000514, 217A-000515, 217A-000516, 217A-000517, 217A-000518, 217A-000519, 217A-000520, 217A-000521, 217A-000522, 217A-000524, 217A-000525, 217A-000526, 217A-000527, 217A-000528, 217A-000529, 217A-000532, 217A-000534, 217A-000535, 217A-000536, 217A-000538, 217A-000539, 217A-000540, 217A-000541, 217A-000542, 217A-000543, 217A-000544, 217A-000545, 217A-000546, 217A-000547, 217A-000548, 217A-000550, 217A-000551, 217A-000552, 217A-000553, 217A-000554, 217A-000555, 217A-000556, 217A-000557, 217A-000558, 217A-000559, 217A-000560, 217A-000561, 217A-000562, 217A-000563, 217A-000564, 217A-000565, 217A-000566, 217A-000567, 217A-000568, 217A-000570, 217A-000571, 217A-000572, 217A-000573, 217A-000574, 217A-000584, 217A-000585, 217A-000586, 217A-000587, 217A-000588, 217A-000589, 217A-000590, 217A-000591, 217A-000592, 217A-000593, 217A-000594, 217A-000595, 217A-000596, 217A-000597, 217A-000598, 217A-000599, 217A-000600, 217A-000601, 217A-000602, 217A-000603, 217A-000604, 217A-000605, 217A-000606, 217A-000608, 217A-000609, 217A-000610, 217A-000611, 217A-000612, 217A-000614, 217A-000615, 217A-000616, 217A-000617, 217A-000618, 217A-000619, 217A-000620, 217A-000621, 217A-000622, 217A-000623, 217A-000624, 217A-000626, 217A-000627, 217A-000628, 217A-000629, 217A-000630, 217A-000631, 217A-000632, 217A-000633, 217A-000634, 217A-000635, 217A-000636, 217A-000637, 217A-000638, 217A-000639, 217A-000640, 217A-000641, 217A-000642, 217A-000643, 217A-000644, 217A-000645, 217A-000646, 217A-000647, 217A-000648, 217A-000649, 217A-000650, 217A-000651, 217A-000652, 217A-000654, 217A-000655, 217A-000656, 217A-000657, 217A-000658, 217A-000659, 217A-000660, 217A-000661, 217A-000662, 217A-000663, 217A-000664, 217A-000665, 217A-000666, 217A-000667, 217A-000668, 217A-000669, 217A-000670, 217A-000671, 217A-000672, 217A-000673, 217A-000674, 217A-000675, 217A-000676, 217A-000677, 217A-000678, 217A-000679, 217A-000680, 217A-000681, 217A-000682, 217A-000683, 217A-000684, 217A-000685, 217A-000686, 217A-000687, 217A-000688, 217A-000691, 217A-000692, 217A-000693, 217A-000694, 217A-000695, 217A-000696, 217A-000697, 217A-000698, 217A-000699, 217A-000700, 217A-000701, 217A-000702, 217A-000703, 217A-000704, 217A-000705, 217A-000706, 217A-000707, 217A-000709, 217A-000710, 217A-000712, 217A-000713, 217A-000715, 217A-000716, 217A-000717, 217A-000718, 217A-000719, 217A-000720, 217A-000721, 217A-000722, 217A-000723, 217A-000724, 217A-000725, 217A-000726, 217A-000727, 217A-000728, 217A-000729, 217A-000730, 217A-000731, 217A-000732, 217A-000733, 217A-000734, 217A-000735, 217A-000736, 217A-000737, 217A-000738, 217A-000739, 217A-000740, 217A-000741, 217A-000742, 217A-000743, 217A-000744, 217A-000745, 217A-000746, 217A-000747, 217A-000748, 217A-000749, 217A-000750, 217A-000751, 217A-000752, 217A-000753, 217A-000754, 217A-000755, 217A-000756, 217A-000757, 217A-000758, 217A-000759, 217A-000760, 217A-000761, 217A-000762, 217A-000763, 217A-000764, 217A-000765, 217A-000766, 217A-000767, 217A-000768, 217A-000769, 217A-000770, 217A-000771, 217A-000772, 217A-000773, 217A-000774, 217A-000775, 217A-000776, 217A-000777, 217A-000778, 217A-000779, 217A-000780, 217A-000781, 217A-000782, 217A-000783, 217A-000784, 217A-000785, 217A-000786, 217A-000787, 217A-000789, 217A-000790, 217A-000791, 217A-000793, 217A-000794, 217A-000796, 217A-000797, 217A-000798, 217A-000799, 217A-000800, 217A-000801, 217A-000802, 217A-000803, 217A-000804, 217A-000805, 217A-000806, 217A-000807, 217A-000809, 217A-000810, 217A-000811, 217A-000812, 217A-000814, 217A-000815, 217A-000816, 217A-000817, 217A-000818, 217A-000819, 217A-000820, 217A-000821, 217A-000822, 217A-000823, 217A-000824, 217A-000825, 217A-000827, 217A-000828, 217A-000829, 217A-000830, 217A-000831, 217A-000832, 217A-000833, 217A-000834, 217A-000835, 217A-000836, 217A-000837, 217A-000838, 217A-000839, 217A-000840, 217A-000842, 217A-000843, 217A-000844, 217A-000845, 217A-000846, 217A-000847, 217A-000848, 217A-000849, 217A-000861, 217A-000863, 217A-000864, 217A-000865, 217A-000866, 217A-000867, 217A-000869, 217A-000870, 217A-000871, 217A-000872, 217A-000873, 217A-000874, 217A-000875, 217A-000876, 217A-000877, 217A-000878, 217A-000879, 217A-000880, 217A-000902, and 217A-000904

Del Mar Reynolds Medical, Ltd., Hertford, United Kingdom, by letter on October 21, 2011. Firm initiated recall is ongoing.

If external pressure is applied to the cuff of the Ambulatory Blood Pressure, Model 90217A, during deflation, the monitor will stop working and display an EC75 error code.

785 units (83 Nationwide and 702 Internationally)

Nationwide and Internationally

VenaCureEVLT Perforator Vein Ablation Kit, Catalog #: EVLT/PVAK, STERILE -- COMMON/USUAL NAME: Laser Surgical Instrument; CLASSIFICATION NAME: Powered Laser Surgical Instrument; DEVICE LISTING # D053485. Product Usage: The 810nm Domed Laser and EVLT Procedure Kit are intended for use in the treatment of superficial vein reflux of the greater saphenous vein associated with varicosities. The Domed D15 plus and D30 plus and EVLT Kits are indicated for treatment of incompetence and reflux of superficial veins in the lower extremity. Recall # Z-0739-2012

Lot Numbers: 005813A, 005813B, 005854, 005854A, 005855, 005856, 005903, 005904, 005905, 005918, 005919, 005920, 005921, 005922, 005929, 005930, 005931, 005932, 005933, 005942, 005943, 005944, 005945, 005946, 005947, 005948, 005966, 005967, 005968, 005969, 005970

Recalling Firm: Angiodynamics Worldwide Headquarters, Latham, NY, by letters dated December 2, 2011.

Manufacturer: Angiodynamics, Inc., Queensbury, NY. Firm initiated recall is ongoing.

The product was labeled with a specific indication for the treatment of perforator veins and this specific indication had not received FDA clearance prior to the product being marketed in the US.

7,640 units

Nationwide

STERRAD 200 Sterilizer, Hydrogen Peroxide Gas Plasma Sterilizer, Chemical Sterilizer. STERRAD 200 (K030429; cleared August 18, 2003) Product Usage: The STERRAD Sterilization System is a low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. Product Code 10201, Recall # Z-0741-2012

None

Advanced Sterilization Products, Irvine, CA, by letter dated December 27, 2011. Firm initiated recall is ongoing.

ASP determined that an internal filter in the vacuum pump on the STERRAD 200 System is subject to wear over time.

395 units

Nationwide and Internationally

1) Brilliance Big Bore CT (Computed Tomography) System, 510 (k) #K033357, Model #728243. The recalled CT systems are equipped with Software Version 3.5 Beta 2. Product Usage: The Brilliance Big Bore is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Recall # Z-0777-2012;

 

2) Brilliance 64 CT (Computed Tomography) System, 510 (k) #K033326, Model #728231, Serial Numbers: 4003, 9875, and 90135. The recalled CT systems are equipped with Software Version 3.5 Beta 2. Product Usage: The Brilliance Big Bore is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Recall # Z-0778-2012;

 

3) Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326. The recalled CT systems are equipped with Software Version 3.5 Beta 2. Product Usage: The Brilliance Big Bore is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Recall # Z-0779-2012

1) Serial Numbers: 7006, 7154, and 7349;

2) Serial Numbers: 4003, 9875, and 90135;

3) Serial Numbers: 300003, 300004, and 300005

Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letters on October 19, 2011. Firm initiated recall is ongoing.

Software errors. A number of non-conformances were logged during in-house testing and external validation testing of Brilliance 64, Brilliance Big Bore, and Ingenuity CT systems, equipped with software version 3.5 Beta 2. The non-conformances are due to software errors identified in these device systems.

9 units

IN, MI, MO, NY, OH, OR, Germany, Israel and Netherlands

1) Mevatron M2/PRIMUS Mid; Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer; Part number 1940035. Recall # Z-0780-2012;

 

2) Mevatron K2; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer; Part number 1940753. Recall # Z-0781-2012;

 

3) PRIMUS HI; Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer; Part number 4504200. Recall # Z-0782-2012;

 

4) Mevatron 77; Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer; Part number 5659503. Recall # Z-0783-2012;

 

5) Mevatron M 7400/7440 (MXE); Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer; Part number 5672977. Recall # Z-0784-2012;

 

6) Mevatron 67; Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer; Part number 5679006. Recall # Z-0785-2012;

 

7) Mevatron M 6700 (MX); Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer; Part number 5693908. Recall # Z-0786-2012;

 

8) Mevatron M 6300 (MX); Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer; Part number 8317000. Recall # Z-0787-2012;

 

9) Mevatron M 6730/6740; Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer; Part number 8317000. Recall # Z-0788-2012;

 

10) Mevatron MD (MD, MDX); Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer; Part number 8319808. Recall # Z-0789-2012;

 

11) Mevatron KD; Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer; Part number 8319857. Recall # Z-0790-2012;

 

12) Mevatron ME; Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer; Part number 8490005. Recall # Z-0791-2012;

 

13) Mevatron KD2; Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer; Part number 8515520. Recall # Z-0792-2012;

 

14) Mevatron M2 6300; Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. Part number 9401316; Recall # Z-0793-2012;

 

15) Mevatron M2 6740; Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer; Part number 9401506. Recall # Z-0794-2012;

 

16) Mevatron MD-2; Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer; Part number 9401654. Recall # Z-0795-2012;

 

17) Mevatron KDS-2; Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer; Part number 9411588. Recall # Z-0796-2012;

 

18) Mevatron KD-2; Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer; Part number 9822685. Recall # Z-0797-2012;

 

19) Mevatron KDS-2; Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer; Part number 9822693. Recall # Z-0798-2012

All units.

Recalling Firm: Siemens Medical Solutions USA, Inc., Concord, CA, by letter on December 1, 2011.

Manufacturer: Siemens Ag Medical Solutions, Kemnath, Germany. Firm initiated recall is ongoing

Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover.

327 active devices

Nationwide and Internationally

Handi-Fil Disposable Syringe Fill Tube P/N 302050, Plastic & Tyvec pouch. The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube; approximately 10 inches in length, with a "J" shaped curve the projects upward approximately two inches. The Handi-Fil Disposable Syringe Fill Tube is used to transfer radiographic contrast media from a sterile vial to an injection syringe. Recall # Z-0815-2012

Lot # 9288021, Exp Date 10-2012; Lot # 0011122, Exp Date 01-2013; Lot # 0095256, Exp Date 04-2013; Lot # 0127196, Exp Date 05-2013; Lot # 0253137, Exp Date 09-2013 & Lot # 0302172, Exp Date 11-2013

Recalling Firm: Mallinckrodt Inc., Cincinnati, OH, byletter dated December 20, 2011.

Manufacturer: Nellcor Puritan Bennett Mexico, S.A. de C.V., Tijuana B.C., Mexico. Firm initiated recall is ongoing.

The firm received complaints from their customers stating that they found open seals on two of their sterilized products.

63,900 units

Nationwide, Australia, Belgium, Canada, Japan and Singapore

Hospira Blood Set, with 200 Micron Filter, 80 Inch, Non-DEHP; an Rx sterile medical device used to administer blood products; 48 individually wrapped sets per case; list 14203-28. Intended use: for the administration of blood products. Recall # Z-0817-2012

Lot 96-146-5H

Recalling Firm: Hospira Inc., Lake Forest, IL, by letter dated January 12, 2012.

Manufacturer: Hospira Holdings de, Costa Rica Ltd., La Aurora de Heredia, Costa Rica. Firm initiated recall is ongoing.

Silicone applied to the piercing pin of the blood set is reducing retention force of the piercing pin while in use. This could cause the piercing pin to slip out of the administration container.

960 units

NC, WA

NAMIC" Convenience Kit --- each unit label contains the customer name under the name of the product, and each catalog number is specific to the customer. Product usage: For use in fluid management and/or invasive pressure monitoring systems Sterile/Non-Sterile UPN Cat Num Sterile Kit H749600183811 60018381; Sterile Kit H749600308161 60030816; Sterile Kit H749600339121 60033912; Sterile Kit H7496005216131 60052161; Sterile Kit H7496005216131 60052161; Sterile Kit H7496005216131 60052161; Sterile Kit H7496005216131 60052161; Sterile Kit H7496005216131 60052161; Sterile Kit H749601621861 60162186; Sterile Kit H749601921911 60192191; Sterile Kit H749602103071 60210307; Sterile Kit H749602103071 60210307; Sterile Kit H749606912341 60691234; Sterile Kit H965600102351 60010235; Sterile Kit H965600104921 60010492; Sterile Kit H965600204051 60020405; Sterile Kit H965600204051 60020405; Sterile Kit H965600206451 60020645; Sterile Kit H965600300681 60030068; Sterile Kit H965600800511 60080051; Sterile Kit H965600800511 60080051; Sterile Kit H965601001351 60100135; Sterile Kit H965601001351 60100135; Sterile Kit H965601001351 60100135; Sterile Kit H965601001351 60100135; Sterile Kit H965601001351 60100135; Sterile Kit H965601001351 60100135; Sterile Kit H965602100141 60210014; Sterile Kit H965602201531 60220153; Sterile Kit H965PK050455S1 PK050455S; Non-Sterile Kit H749650300641 65030064; Non-Sterile Kit H749650300641 65030064; Non-Sterile Kit H749650302721 64030272; Non-Sterile Kit H749651106561 65110656; Non-Sterile Kit H749651106561 65110656; Non-Sterile Kit H749656900411; Non-Sterile Kit H965650200691 65020069; Non-Sterile Kit H965651949131 65194913; Non-Sterile Kit H965651949131 65194913; Non-Sterile Kit H9656522016141 652201614; Non-Sterile Kit H9656522016141 652201614. Recall # Z-0821-2012

Lot numbers: 4163389; 4155011; 4167674; 4148470; 4152176; 4166769; 4168829; 4170180; 4173288; 4155123; 4155130; 4160686; 4175188; 4155678; 4153182; 4155226; 4172242; 4155233; 4166803; 4155288; 4169451; 4154699; 4165389; 4168350; 4169879; 4172683; 4176389; 4160703; 4155363; 4177156; 4148480; 4168790; 4167954; 4169591; 4172687; 4166791; 4174714; 4167686; 4170421

Navilyst Medical, Inc., Glens Falls, NY, by letter dated December 19, 2011. Firm initiated recall is ongoing.

Navilyst Medical has received reports of damaged manifolds contained in certain NAMIC Convenience Kits which may result in air injection during certain procedures.

4,547 kits

Nationwide

1) Olympus Endoscopic Electrosurgical Unit working elements, model numbers WA22066A and WA22067A. Working element for endoscopic diagnosis and treatment in urological and gynecological applications. Recall # Z-0828-2012;

 

2) Olympus Endoscopic Electrosurgical Unit working elements, model numbers WA22366A, and WA22367A. Working element for cutting, coagulation, and vaporization in conductive irrigation fluid or conductive distension medium in the Saline mode. Recall # Z-0829-2012

1) and 2) Lot numbers 118W, 119W, and 11XW for new inventory

Recalling Firm: Olympus America Inc., Center Valley, PA, by letter dated December 27, 2011.

Manufacturer: Olympus Winter & Ibe Gmbh & Co., Hamburg, Germany. Firm initiated recall is ongoing.

Less than optimal thickness in the plastic housing holding the electrode in the Olympus Working Elements.

591 units

Nationwide

GE eXplore Locus Micro CT cabinet x-ray system model RS9-80. CT Scanner for laboratory mice or other research. Part Number 5134163. Recall # Z-0833-2012

None

GE Healthcare, LLC, Waukesha, WI, via Field Modification Instructions IFMI, which is scheduled for deployment on March 1, 2011. Firm initiated recall is ongoing.

Product fails to comply with the federal performance standard for cabinet x-ray systems (Title 21 CFR 1020.40(c)(1)(i)). Specifically, the x-ray emission limit of 0.5 milliroentgen in one hour could be exceed. Highest emission measured was 3 mR/hr.

44 units

Nationwide and Internationally

The SternaLock Blu Implant Tray includes plates, screws, screw measuring device, and blades. The SternaLock Blu Implant Tray would have been found within the following outer containers: Silver Instrument Tray, with a White rack, and there is no Power Driver warning. Labeled in part: #73-1301***STERNALOCK IMPLANT TRAY***256X 125.5 MM (10.080 x 4.940 ") (LXW) ***Polypropylene, Aluminum, Stainless Steel***" A 3" tall container, with blue rubber handles, and a Power Driver warning on the container lid. Labeled in part: "***#73-1302***STERNALOCK BLU IMPLANT TRAY SEMIMODULAR***256X 125.5 MM (10.080 x 4.940 ") (LXW) Polypropylene, Aluminum, Stainless Steel***" A 5" tall container, with a wide metal latch to secure the lid, and there is no Power Driver warning. Labeled in part: "***#73-1300*** STERNALOCK BLU IMPLANT SEMI MODULAR TRAY***228.6X 128.8MM (9.00 x 5.07 ") (LXW)Polypropylene, Aluminum, Radel***". The Biomet Microfixation SternaLock Blu System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures to aid in the alignment and stabilization of bone. There SternaLock instrument tray has been designed specifically to store the implants for this system. a) Model Number 73-1300; b) Model Number 73-1301; c) Model Number 73-1302. Recall # Z-0843-2012

a) Lot numbers: 032211, 042911, 100611; b) Lot numbers: 249640, 280130, 280131, 312560, 031411; c) Lot number: 011411

Biomet Microfixation, Inc., Jacksonville, FL, by letter on November 23, 2011. Firm initiated recall is ongoing.

Recall due to the possibility of an inaccurate reading on the Screw Measuring Area. If used incorrectly, the screw measuring area inside the SternaLock Blu Implant Tray, could lead to the improper selection of a screw 2mm longer than needed.

109 trays

Nationwide, Argentina, Australia, Canada, Denmark, Finland, Germany, South Africa, and Spain

CellTracks Analyzer II. A semi-automated fluorescence microscope used to enumerate fluorescently labeled cells that are immuno-magnetically selected and aligned. The system is for in-vitro diagnostic use when used in tandem with specimen preparation equipment and reagents that are legally marketed for in vitro diagnostic use with this device. Product code 9555. Recall # Z-1004-2012

Lot: K050145, March 15, 2005; K060110, March 16, 2006

Veridex, LLC, Raritan, NJ, by letter dated August 17, 2011. Firm initiated recall is ongoing.

Control cell images may i intermix with Patient cell images while changing between the Control review screen and Patient review screen on the Cell tracks Analyzer II.

37 units

Nationwide and Internationally

1) DYNASTY(R) BIOFOAM(R) SHELL, Size: 46mm GROUP B, REF DSBFGB46, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component. The instrument is used as a hip acetabular shell. Recall # Z-1016-2012;

 

2) DYNASTY(R) BIOFOAM(R) SHELL, Size: 48mm GROUP B, REF DSBFGB48, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component. The instrument is used as a hip acetabular shell. Recall # Z-1017-2012;

 

3) DYNASTY(R) BIOFOAM(R) SHELL, Size: 50mm GROUP C, REF DSBFGC50, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component. The instrument is used as a hip acetabular shell. Recall # Z-1018-2012;

 

4) DYNASTY(R) BIOFOAM(R) SHELL, Size: 52mm GROUP D, REF DSBFGD52, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component. The instrument is used as a hip acetabular shell. Recall # Z-1019-2012;

 

5) DYNASTY(R) BIOFOAM(R) SHELL, Size: 54mm GROUP E, REF DSBFGE54, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component. The instrument is used as a hip acetabular shell. Recall # Z-1020-2012;

 

6) DYNASTY(R) BIOFOAM(R) SHELL, Size: 56mm GROUP F, REF DSBFGF56, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component. The instrument is used as a hip acetabular shell. Recall # Z-1021-2012

 

7) DYNASTY(R) BIOFOAM(R) SHELL, Size: 58mm GROUP G, REF DSBFGG58, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component. The instrument is used as a hip acetabular shell. Recall # Z-1022-2012;

 

8) DYNASTY(R) BIOFOAM(R) SHELL, Size: 60mm GROUP G, REF DSBFGG60, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component. The instrument is used as a hip acetabular shell. Recall # Z-1023-2012;

 

9) DYNASTY(R) BIOFOAM(R) SHELL, Size: 62mm GROUP G, REF DSBFGG62, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component. The instrument is used as a hip acetabular shell. Recall # Z-1024-2012;

 

10) DYNASTY(R) BIOFOAM(R) SHELL, Size: 64mm GROUP H, REF DSBFGH64, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component. The instrument is used as a hip acetabular shell. Recall # Z-1025-2012;

 

11) DYNASTY(R) BIOFOAM(R) SHELL, Size: 66mm GROUP H, REF DSBFGH66, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component. The instrument is used as a hip acetabular shell. Recall # Z-1026-2012;

 

12) DYNASTY(R) BIOFOAM(R) SHELL, Size: 68mm GROUP H, REF DSBFGH68, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component. The instrument is used as a hip acetabular shell. Recall # Z-1027-2012;

 

13) DYNASTY(R) BIOFOAM(R) SHELL, Size: 70mm GROUP J, REF DSBFGJ70, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component. The instrument is used as a hip acetabular shell. Recall # Z-1028-2012;

 

14) DYNASTY(R) BIOFOAM(R) SHELL, Size: 72mm GROUP J, REF DSBFGJ72, Rx ONLY, STERILE R, hip prosthesis acetabular component. The instrument is used as a hip acetabular shell. Recall # Z-1029-2012;

 

15) DYNASTY(R) BIOFOAM(R) SHELL, Size: 74mm GROUP J, REF DSBFGJ74, Rx ONLY, STERILE R, hip prosthesis acetabular component. The instrument is used as a hip acetabular shell. Recall # Z-1030-2012;

 

16) DYNASTY(R) BIOFOAM(R) SHELL, Size: 76mm GROUP K, REF DSBFGK76, Rx ONLY, STERILE R, hip prosthesis acetabular component. The instrument is used as a hip acetabular shell. Recall # Z-1031-2012

1) Lot Numbers: 069846528, 119925740, 010970893, 020998825, 079853470, 79859628, 079868615, 089870267, 089875761, 089878278, 099890880, 099907005, 109917381, 109921935, 119925740, 119930199, 129937584, 0201014640, 0311295429, 0401072697, 0501102202, 0611368642, 0711367603, 0711367604, 0801144244, 0801150043, 0901165305, 04189088001, 04193758401, 04198097901, 05983919310, 05984293410, 06984652810;

 

2) Lot Numbers: 1374827, 010969758, 010975153, 020983746, 020998826, 069852741, 079863314, 079868616, 079874282, 079898400, 089876862, 089881419, 099891611, 099911432, 099915876, 109919437, 119923987, 119927417, 119935682, 129964135, 0311295431, 0401051289, 0401065581, 0401072698, 0501014641, 0711361480, 0711361481, 0711361482, 0801144250, 0801150044, 06984480510, 05983999210, 06984815910;

 

3) Lot Numbers: 1260211, 1374830, 1374831, 1374832, 1388092, 1388093, 1388094, 1400105, 020976448, 020983747, 020988026, 079852742, 079859618, 079868617, 089870268, 099890881, 109917383, 0111241002, 0111260211, 119923303, 119928416, 119932052, 119934130, 129937585, 129958768, 0211275869, 0211286113, 0411327738, 0411327740, 0501027671, 0501035745, 0501047116, 0501055976, 0501065582, 0501082868, 0501099069, 0501102204, 0501110435, 0511336665, 0601125073, 0611365440, 0611373889, 0611373983, 0701146264, 0711364801, 0711367605, 0711367606, 0711367607, 0711367608, 0711369702, 0711369703, 0711369704, 0801144251, 0801150045, 0801157678, 0901178538, 1001197012, 1101186485, 1101216631, 04096712101, 05984480710;

 

4) Lot Numbers: 1373320, 1373321, 1374833, 1374834, 1374835, 1378882, 1378883, 1378884, 1381106, 1381174, 1391376, 1391377, 1391378, 010968477, 010970896, 020988029, 079853471, 089881420, 089891612, 109923307, 109925741, 0111210356, 0111225702, 0111235659, 0111241003, 0111247697, 119928417, 129965093, 0211260212, 0211275870, 0211286114, 0311291335, 0401034758, 0401051290, 0401055977, 0511327742, 0511336666, 0511336668, 0511344242, 0511344243, 0601141363, 0611368720, 0611374034, 0611374039, 0611378097, 0611378115, 0611380707, 0611380712, 0711364802, 0711367609, 0711373322, 0801144252, 0801150046, 0801158942, 0801165301, 0801165306, 0801170858, 0801178539, 0801184423, 1001186475, 1001197037, 1001200098, 1001201699, 1101216630, 1201211101, 1201216627, 03098098001, 05984480810, 06984816110;

 

5) Lot Numbers: 1373323, 1373324, 1373325, 1374842, 1378891, 1381021, 1381022, 1381023, 1388095, 1393853, 1393854, 1400101, 1401174, 1404092, 1405127, 010968478, 010973155, 020988034, 079868619, 089876863, 0111225746, 0111235664, 0111241004, 119935686, 129941901, 129965094, 129966048, 0201012354, 0201018596, 0211247698, 0211260213, 0211286115, 0401036850, 0411321263, 0411321264, 0411327743, 0411327744, 0501027020, 0501045918, 0501095719, 0511336663, 0511336664, 0511344244, 0511344245, 0601125075, 0611373991, 0611373992, 0611377759, 0611380738, 0701148277, 0711364803, 0711364804, 0711369706, 0711369707, 0711369708, 0711380724, 0801144253, 0801148528, 0801150047, 0801158943, 0801165303, 0801170860, 0801178540, 0801184424, 1001186476, 1001189885, 1001197060, 1101200099, 1201210358, 1201211102, 1201216628, 05984260810, 070114136401;

 

6) Lot Numbers: 842609, 1373327, 1374836, 1374841, 1378885, 1378886, 1378887, 1388096, 1388098, 1393855, 1401332, 1405228, 1405233, 010969761, 010973158, 020976449, 020983750, 020998829, 079874283, 099907007, 0111200104, 0111225803, 0111241005, 119928418, 119932054, 119934132, 129937587, 129958770, 129966049, 0201010185, 0201016141, 0211216629, 0211235666, 0211247704, 0211256648, 0211275871, 0311291336, 0311295433, 0401027672, 0401047122, 0401051291, 0401082870, 0501102207, 0501112341, 0511344246, 0511344247, 0601125076, 0611373193, 0611380773, 0701148278, 0711361483, 0711361484, 0711361485, 0711373326, 0711373328, 0711380787, 0711381258, 0801144282, 0801146267, 0801148529, 0801150054, 0801158944, 0801165304, 0801178541, 0801184425, 1101189886, 1101210360, 1101211103, 1101220321, 05983592110;

 

7) Lot Numbers: 1235669, 1378888, 1378889, 1378890, 1381024, 1381025, 1381026, 1393502, 010969762, 020973160, 020976450, 020998830, 079874284, 099891614, 099911435, 109919439, 109921941, 119932930, 119935689, 129965096, 129967122, 0201010186, 0201020901, 0211256649, 0211290267, 0311291334, 0411321265, 0411321266, 0501027673, 0501045920, 0501047123, 0501051292, 0501078398, 0501095721, 0501099075, 0501110610, 0511336670, 0601117005, 0601141366, 0611368383, 0611368384, 0611374010, 0611378017, 0611378060, 0711364805, 0711364806, 0711364807, 0801144283, 0801150055, 0801157114, 0901148279, 0901148530, 0901165310, 0901184426, 1101197061, 1101201702, 1101216632, 05983592210, 040101018601;

 

8) Lot Numbers: 079868628, 1381030, 1388097, 1393856, 1393857, 010970898, 020980982, 050988038, 069850102, 079874285, 099898324, 099914623, 109919440, 109921942, 109925742, 119930202, 119932931, 129966043, 129967123, 0201001768, 0211256650, 0301023179, 0501014643, 0501027674, 0501035748, 0501047117, 0501055979, 0501082871, 0501099070, 0501110611, 0501112343, 0501117006, 0611344248, 0611373194, 0611378062, 0611378106, 0711364808, 0711364846, 0711367610, 0801144284, 0801150056, 0901146269, 1201201703, 1201220323, 06984653810;

 

9) Lot Numbers: 1391379, 010969772, 010975155, 020990550, 079852744, 079859624, 079863023, 079870271, 089876865, 089883150, 099898325, 099914624, 109920348, 109923990, 119927440, 119932933, 129964147, 0201010187, 0301016465, 0301023180, 0501059800, 0601117007, 0601125077, 0611368730, 0611373960, 0611374040, 0711369709, 0801144303, 0801150057, 05983919510, 06984480910, 06984653910, 06984816310;

 

10) Lot Numbers: 1381104, 1393761, 010968480, 020976451, 020990551, 069852745, 079853475, 079859625, 079868631, 079870272, 079874286, 089878280, 099890882, 099907008, 099915879, 109920349, 129928419, 129966044, 0301014644, 0501035749, 0501056061, 0501059801, 0611372684, 0611374041, 0711367611, 0711367612, 0711380789, 0801144306, 0801150058, 05983920210, 05984481010, 06984816410;

 

11) Lot Numbers: 129964151, 010967125, 010975156, 020990552, 069894417, 079863025, 079870273, 079875765, 089878281, 089890883, 099898326, 099914625, 119927442, 119932055, 0301014645, 0501027675, 0501035750, 0501059802, 0501065583, 0801144308, 0801150059, 05983920410, 05984481110, 06984816510;

 

12) Lot Numbers: 842614, 010966046, 010968481, 010975157, 050980983, 079850103, 079853480, 079870274, 079874287, 089876866, 089886488, 099898327, 099914626, 119921943, 119930203, 129932932, 129941903, 0501010188, 0801144312, 0801150060, 05983919810, 05984261410, 06984654010;

 

13) Lot Numbers: 1199489, 010970900, 109923311, 119945554, 119948954, 0301016142, 0401051293, 0501034761, 0801027021;

 

14) Lot Numbers: 030990547, 119925743, 119934133, 129941904, 0501027022, 0601078395

 

15) Lot Numbers: 0301028247, 0501034762, 0501078396;

 

16) Lot Numbers: 119925745, 129941906, 129964152, 0401027024, 0401047124, 0401055980, 0401065584, 04096415201

Wright Medical Technology Inc., Arlington, TN, by letter dated December 27, 2011.

Firm initiated recall is ongoing.

The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery.

5342 devices

Nationwide, Australia, Brazil, Canada, Denmark, and Italy

The 1500T9 Cardiac Ablation Generator, RO#lBl-89000 is part of the Therapy Cardiac Ablation System, along with the Cool Point irrigation Pump, the Therapy 1300 Series Steerable Ablation Catheters, the Therapy Cool Path Ablation Catheters and accessories. The generator is a microprocessor-controlled device that produces a continuous unmodulated radiofrequency (RF) output delivered from the generator between its tip electrode and a dispersive pad for the treatment of atrial flutter. Recall # Z-1032-2012

Serial numbers: 13826729 and 13827596

St Jude Medical Inc., Saint Paul, MN, by letter dated January 5th, 2012. Firm initiated recall is ongoing.

Generator units were distributed to customers while still under FDA review as part of a PMA supplement to the approved PMA applications.

2 units

KS, MD

1) S.M.A.R.T. CONTROL Transhepatic Biliary Stent and PRECISE RX Transhepatic Biliary Stent. The Self-Expanding Nitinol Biliary Stents are delivered by catheter for the palliation of malignant neoplasms in the biliary tree. Model numbers are CxxyyyMB, CxxyyySB, CxxyyyML, and CxxyyySL, where xx is the stent diameter in mm and yyy is the stent length in mm; but not including catalogs where yyy is 120 or 150. The Removal only includes Catalog Numbers in the above sequence with S.M.A.R.T CONTROL in the logo/description. Catalog Numbers: C09080MB, C09080SB, C10080MB, C10080SB, C12030MB, C12030SB, C12040MB, C12040SB, C12060MB, C12060SB, C12080MB, C12080SB, C14030MB, C14030SB, C14040MB, C14040SB, C14060MB, C14060SB, C14080MB, C14080SB. Recall Z-1039-2012;

 

2) S.M.A.R.T. CONTROL NITINOL STENT SYSTEM ILIAC: Self-Expanding Vascular Stents delivered by catheter for the indication of improving luminal diameter in patients with symptomatic atherosclerotic disease of the iliac arteries. catalog numbers are CxxyyyMB, CxxyyySB, CxxyyyML, and CxxyyySL, where xx is the stent diameter in mm and yyy is the stent length in mm; but not including catalogs where yyy is 120 or 150. The Removal only includes Catalog Numbers in the above sequence with S.M.A.R.T. CONTROL in the logo/description. Catalog Numbers: C06020ML, C06020SL, C06030ML, C06030SL, C06040ML, C06040SL, C06060ML, C06060SL, C06080ML, C06080SL, C06100ML, C06100SL, C07020ML, C07020SL, C07030ML, C07030SL, C07040ML, C07040SL, C07060ML, C07060SL, C07080ML, C07080SL, C07100ML, C07100SL, C08020ML, C08020SL, C08030ML, C08030SL, C08040ML, C08040SL, C08060ML, C08060SL, C08080ML, C08080SL, C08100ML, C08100SL, C09020ML, C09020SL, C09030ML, C09030SL, C09040ML, C09040SL, C09060ML, C09060SL, C10020ML, C10020SL, C10030ML, C10030SL, C10040ML, C10040SL, C10060ML, C10060SL. Recall # Z-1040-2012

All unexpired lot numbers 15112447 through 15525516.

Cordis Corp., Miami Lakes, FL, by letter dated January 31, 2012. Firm initiated recall is ongoing.

Recall due to a potential sterility breach in the pouches.

150,000 units

Nationwide and Japan, Canada, Mexico, South Korea, and Taiwan

TruFlight Select PET/CT System equipped with software version 3.5.3.10, Model #459800111661. A diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. Recall # Z-1056-2012

Software version 3.5.3.10, Serial Numbers: 17002 and 17003

Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter dated December 13, 2011. Firm initiated recall is ongoing.

A number of non-conformances have been noted in the TruFlight Select PET/CT System. A number of these non-conformances have been corrected to improve the overall quality and functionality of the suspect system units.

2 units

OH, MD

Siemens syngo Imaging XS. Radiological image processing system. Model number 10496279. Recall # Z-1064-2012

Serial numbers 1344, 1744, 1187, 2981, 1361, 3052, 3053, 3054, 3055, 3056, 3057, 3058, 3059, 3060, 3061, 2323, 2254, 1088, 1089, 2194, 2195, 1213, 1214, 1188, 1189, 3086, 2626, 1828, 1624, 1625, 2878, 2365, 2366, 3087, 3088, 3089, 2500, 2971, 1424, 1425, 3093, 2890, 1371, 1372, 3062, 2267, 2268, 2269, 1856, 1857, 2695, 2696, 3010, 1373, 1374, 1375, 1376, 1377, 1713, 1712, 2408, 2409, 2559, 2560, 2561, 2562, 1735, 1668, 2098, 1190, 1418, 2069, 2698, 2769, 1884, 1381, 1382, 1378, 1379, 1380, 1165, 2310, 2311, 2312, 2448, 2449, 2450, 2670, 2671, 2672, 2673, 2674, 2675, 2676, 2677, 2678, 2679, 2324, 1940, 1395, 2901, 2897, 2898, 2899, 2900, 2934, 3017, 2144, 2145, 2146, 2147, 2148, 2149, 2150, 2151, 2152, 2153, 2154, 2155, 2156, 2157, 2158, 2159, 2200, 2201, 1383, 3050, and 3085

Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter on January 26, 2011.

Manufacturer: Siemens AG, Medical Solutions, Business Unit XP, Erlangen, Germany. Firm initiated recall is ongoing.

Firm became aware of an unintended behavior when using syngo Imaging XS, version VA70A and VA70B with Client/Server Installations. Loading additional images/series from the Patient Browser using the thumbnails may cause unintended deletion of images/series. In response, firm issued a Customer Safety Advisory Notice to affected customers via Update Instructions SY047/11/S. Additionally; firm became aware of an unintended behavior when using syngo Imaging XS, all versions. The "Rename" function may cause an unintended patient merge if the renamed patient is sent to another system. In response to this issue, firm distributed a Customer Safety Advisory Notice to affected customers via Update Instructions SY038/11/S. Both letters informed customers of the potential issues and provided additional information on the implemented resolution. The current Update Instruction SY055/11/S is the subsequent measure announced in the customer safety advisory notices UI SY047/11/S and UI SY038/11/S. To remedy the issues described in customer safety advisory notices, a software update package VA70B_0211 is being released.

128 units

Nationwide

1) AngioDynamics SPECIAL ORDER Morpheus Smart PICC CT --- 5F Dual Lumen 65cm --- Max CT Flow Rate: 4mL/sec --- Kit Contains: --- 1 each Nitinol Guidewire, 0.46mm (0.018in.) x 130cm --- Catalog No. [REF] 52110901 --- [Mfg symbol]. Indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. Recall # Z-1068-2012;

 

2) AngioDynamics SPECIAL ORDER Morpheus Smart PICC CT --- 4F Single Lumen 65cm --- Max CT Flow Rate: 4mL/sec --- Kit Contains: --- 1 each Nitinol Guidewire, 0.46mm (0.018in.) x 130cm --- Catalog No. [REF] 52110902 --- [Mfg symbol]. Indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. Recall # Z-1069-2012

1) Lot 549559;

2) Lot 549560

Recalling Firm: Angiodynamics Worldwide Headquarters, Latham, NY, by letter dated February 2, 2012.

Manufacturer: Angiodynamics, Inc., Queensbury, NY. Firm initiated recall is ongoing.

The Morpheus Smart PICC label states the kit contains a Nitinol guidewire; however the kit contains a Platinum guidewire.

50 units

WI

Discovery Elbow System Humeral Condyle Set- Hexalobular, REF 114700, Alloy, Sterile. Intended for primary and revision joint arthroplasty for use in cemented applications. Recall # Z-1071-2012

Lot 797550

Biomet, Inc., Warsaw, IN, by letter on December 14, 2011. Firm initiated recall is ongoing.

A Discovery Condyle Kit w/ Hexalobula was opened during an elbow joint replacement surgery, and was found to contain two male condyles.

10 units

Netherlands & UK

CORFLO-Ultra Jejunal Tube with CORLOCK-Twoomey Y-Adaptor for use with the CORFLO-Max PEG; enteral feeding tube,10 Fr, 36" (91 cm), 3 Gram weighted bolus; individually packaged, 5 tubes per case; catalog/reorder #30-7361; For delivery of enteral nutrition Product Usage: For delivery of enteral nutrition. Recall # Z-1080-2012

Lot 46121, expiration: 2016-10

Recalling Firm: Corpak Med Systems, Buffalo Grove, IL, by letter dated January 27, 2012.
Manufacturer: CORPAK MedSystems, Wheeling, IL. Firm initiated recall is ongoing.

The wrong size Twoomey adapter was packaged with the Jejunal tube.

145 units

Nationwide and Sweden and New Zealand

Microsoft Amalga - previously known as Microsoft Amalga Unified Intelligence System (UIS) 2009 Product Usage: Microsoft Amalga UIS 2009 enables healthcare providers to create a comprehensive continually updated data ecosystem to aggregate, store, display, and share disparate data either coming from many source systems or directly entered by end users for rapid self-service data exploration and analysis by front line managers, clinicians and ancillary staff. Furthermore, Amalga UIS allows healthcare providers to rapidly create new applications to respond to evolving business and clinical needs. Recall # Z-1082-2012

Software Version: R2 SP2, RTM, R2 SP3

Microsoft Corporation Health Solutions Group, Redmond, WA, letter dated January 5, 2012. Firm Initiated recall is ongoing.

Healthcare providers reported that when sharing a single browser session on Amalga Web, patient A's data can be displayed under patient B's name.

9 units

CA, KY, NC, WI, China, Switzerland

1) UltraVision Detection System; Anti-Polyvalent, Alk-Phos/BCIP/NBT (Ready to Use) Product Usage: These products detect specific antibodies bound to an antigen in tissue sections. The specific antibody is located by a biotin-conjugated secondary antibody. This step is followed by the addition of streptavidin-enzyme conjugate that binds to the biotin preset on the secondary antibody. The specific antibody, secondary antibody, and streptavidin-enzyme complex is then visualized with an appropriate substrate/chromogen. Catalog number: TP-015-AB. Recall # Z-1083-2012;

 

2) UltraVision Detection System; Anti-Polyvalent, Alk-Phos/Fast Red (Ready to Use) Product Usage: These products detect specific antibodies bound to an antigen in tissue sections. The specific antibody is located by a biotin-conjugated secondary antibody. This step is followed by the addition of streptavidin-enzyme conjugate that binds to the biotin preset on the secondary antibody. The specific antibody, secondary antibody, and streptavidin-enzyme complex is then visualized with an appropriate substrate/chromogen. Catalog number: TP-015-AF. Recall # Z-1084-2012;

 

3) UltraVision Plus Detection System; Anti-Polyvalent, Alk-Phos/Fast Red (Ready to Use) Product Usage: These products detect specific antibodies bound to an antigen in tissue sections. The specific antibody is located by a biotin-conjugated secondary antibody. This step is followed by the addition of streptavidin-enzyme conjugate that binds to the biotin preset on the secondary antibody. The specific antibody, secondary antibody, and streptavidin-enzyme complex is then visualized with an appropriate substrate/chromogen. Catalog number: TP-015-AFX. Recall # Z-1085-2012;

 

4) UltraVision Large Volume Detection System; Anti-Polyvalent, Alk-Phos (Ready to Use) Product Usage: These products detect specific antibodies bound to an antigen in tissue sections. The specific antibody is located by a biotin-conjugated secondary antibody. This step is followed by the addition of streptavidin-enzyme conjugate that binds to the biotin preset on the secondary antibody. The specific antibody, secondary antibody, and streptavidin-enzyme complex is then visualized with an appropriate substrate/chromogen. Catalog number: TP-060-AL; Catalog number TP-125-AL. Recall # Z-1086-2012;

 

5) UltraVision Plus Large Volume Detection System; Anti-Polyvalent, Alk-Phos (Ready to Use) Product Usage: These products detect specific antibodies bound to an antigen in tissue sections. The specific antibody is located by a biotin-conjugated secondary antibody. This step is followed by the addition of streptavidin-enzyme conjugate that binds to the biotin preset on the secondary antibody. The specific antibody, secondary antibody, and streptavidin-enzyme complex is then visualized with an appropriate substrate/chromogen. Catalog number: TP-060-ALX; Catalog number TP-125-ALX. Recall # Z-1087-2012;

 

6) UltraVision Detection System; Anti-Rabbit, Alk-Phos/BCIP/NBT (Ready to Use) Product Usage: These products detect specific antibodies bound to an antigen in tissue sections. The specific antibody is located by a biotin-conjugated secondary antibody. This step is followed by the addition of streptavidin-enzyme conjugate that binds to the biotin preset on the secondary antibody. The specific antibody, secondary antibody, and streptavidin-enzyme complex is then visualized with an appropriate substrate/chromogen. Catalog number: TR-015-AB. Recall # Z-1088-2012;

 

7) Streptavidin Alkaline Phosphatase (Ready to Use) Product Usage: These products detect specific antibodies bound to an antigen in tissue sections. The specific antibody is located by a biotin-conjugated secondary antibody. This step is followed by the addition of streptavidin-enzyme conjugate that binds to the biotin preset on the secondary antibody. The specific antibody, secondary antibody, and streptavidin-enzyme complex is then visualized with an appropriate substrate/chromogen. a) Catalog number: TS-060-AP; b) Catalog number: TS-125-AP. Recall # Z-1089-2012

1) Lot number: PAB110214, Exp. 4/2012; Lot number: PAB110830, Exp. 10/2012

 

2) Lot Number: PAF110420, Exp. 4/2012; Lot Number: PAF110503, Exp 6/2012; Lot number: PAF110722, Exp 9/2012;

 

3) Lot Number: AFX1104027, Exp. 6/2012; Lot Number: AFX110705, Exp 8/2012;

 

4) Lot Number: PAL110310, Exp. 12/2012; Lot Number: PAL110325, Exp 1/2013; Lot Number: PAL111019, Exp. 10/2012;

 

5) Lot Number: ALX110518, Exp. 11/2012; Lot Number: ALX110705, Exp 12/2012

 

6) Lot Number: RAB110810, Exp. 10/2012;

 

7) a) Lot Number: SAP101207, Exp 6/2012; Lot Number: SAP110216, Exp 2/2013; b) Lot Number: SAP110106, Exp. 1/2013; Lot Number: SAP110405, Exp 10/2012

Lab Visi on Corp., Fremont, CA, by letters dated January 11, 2012. Firm initiated recall is ongoing

Firm was notified by vendor that a component in kits was not meeting internal specifications. Declination in product performance confirmed by Thermo Fisher.

31 kits

FL, IL, MA, TX and Denmark, Turkey, Italy, Poland, Canada, Japan, Germany, Egypt and Greece

ARTISTE, ONCOR and PRIMUS Linear Accelerators with RT Therapist Workspace, version 4.1. The indication is to deliver X-ray, photon and electron radiation for the therapeutic treatment of cancer. Syngo RT Therapist v4.1, part number 8162815; Syngo RT Therapist Assist (off line system), part number 8162807; Syngo RT Express Basic (stand alone system), part number 8151289; and Syngo RT Express Assist (offline system), part number 8151297. Recall # Z-1092-2012

Version 4.1

Siemens Medical Solutions USA, Inc., Concord, CA, by letter beginning January 22, 2012. Firm initiated recall is ongoing.

Software upgrade to installed base to the latest release of the RT Therapist version 4.1.144 which corrects multiple safety issues that could lead to patient mistreatment.

182 active devices

Nationwide and Internationally

BD Oral Dispensing Syringe Oral Syringe Tip Caps various sizes ( 1 mL, 3 mL, 5 mL. 10 mL BD, Ref Numbers 305207, 305218, 305210, 305220, 305208, 305218, 305219 Product Usage: Used for the oral administration of medications. Pre-amendment device, Device Listing Number R060456. Recall # Z-1097-2012

Lot Number Catalog Number 0240048 305219 0267416 305207 0267418 305207 0267422 305209 0267423 305209 0267425 305217 0267426 305217 0267430 305219 0267432 305219 0294722 305210 0294726 305210 0294727 305217 0294729 305220 0294730 305220 0294731 305208 0296604 305218 0296605 305218 0296606 305218 0296607 305218 0296608 305207 0296609 305207 0296610 305217 0296611 305217 0296614 305219 0296615 305219 0323224 305207 0323225 305207 0323228 305210 0323229 305217 0323230 305218 0323231 305218 0323232 305218 0323233 305219 0323235 305220 0323329 305217 0323332 305210 0323333 305210 0323334 305220 0323335 305220 0323336 305220 1003672 305219 1003675 305219 1003679 305218 1003681 305218 1003683 305218 1003684 305207 1003686 305207 1003690 305207 1003691 305208 1003692 305208 1003693 305209 1003696 305209 1003699 305217 1027148 305207 1027150 305207 1027154 305208 1027156 305208 1027159 305209 1027161 305209 1027164 305210 1027166 305210 1027168 305217 1027174 305218 1027175 305218 1027179 305219 1027183 305219 1027184 305220 1042244 305218 1052674 305207 1052675 305207 1052676 305217 1052677 305217 1052678 305217 1052679 305208 1052680 305208 1052681 305218 1052682 305210 1052683 305220 1052684 305220 1052685 305209 1052686 305209 1052687 305219 1052688 305219 1080129 305210 1081310 305218 1081712 305208 1082759 305218 1082761 305220 1082778 305207 1082783 305217

Recalling Firm: Becton Dickinson & Company. Franklin Lakes, NJ, by letters dated October 5, 2011.

Manufacturer: Becton Dickinson Medical Systems, Canaan, CT. Firm initiated recall is ongoing.

There are complaint reports for loose tip caps in various types of oral syringes.

22,827,500 units

Nationwide

Breeze Self-Adhesive Resin Cement, part number: N97F. The intended use is for cementation of porcelain, resin, and metal-based inlays, onlays, crowns, bridges, and posts. Recall # Z-1100-2012

Lot # 200466

Kerr Corp., Orange, CA, by letter on December 17, 2010. Firm initiated recall is complete.

The Breeze Self-Adhesive Resin Cement exhibits faster than expected gel and set times. If the work time is exceeded when using this material, it could possibly result in inadequate bond strength.

622 units total (12 units in US)

Nationwide and Vietnam, Jordan, Turkey, and Italy

Oral-Eze (R) Oral Fluid Collection System, Product Usage: IVD for drugs of abuse. Recall# Z-1101-2012

Lot #, Expiration date: 07192011, exp. 04-30-2013; 07202011, exp. 04-31-2013; 07212011, exp. 04-31-2013; 07222011, exp. 05-31-2013; 07252011, exp. 05-31-2013; 07262011, exp. 05-31-2013; 07272011, exp. 05-31-2013; 07282011, exp. 05-31-2013; 07292011, exp. 05-31-2013; 07302011, exp. 05-31-2013; 07312011, exp. 05-31-2013; 08012011, exp. 05-31-2013; 08022011, exp. 05-31-2013; 08032011, exp. 05-31-2013; 08042011, exp. 05-31-2013; 08052011, exp. 05-31-2013; 08062011, exp. 05-31-2013; 08072011, exp. 05-31-2013; 08082011, exp. 05-31-2013; 08092011, exp. 05-31-2013; 08102011, exp. 05-31-2013; 08112011, exp. 05-31-2013; 08122011, exp. 05-31-2013; 08132011, exp. 05-31-2013; 08142011, exp. 05-31-2013; 08152011, exp. 05-31-2013; 08162011, exp. 05-31-2013; 08172011, exp. 05-31-2013; 08182011, exp. 05-31-2013; 08192011, exp. 05-31-2013; 08212011, exp. 05-31-2013; 08222011, exp. 05-31-2013; 08232011, exp. 05-31-2013; 08242011, exp. 05-31-2013

Capitol Vial Inc., Auburn, AL, by letter dated October 7, 2011. Firm initiated recall is ongoing.

Low buffer fill volumes on Oral-Eze, an oral fluid collection system.

135,000 units

Nationwide

V Series Monitor. The Indications for Use for the V Series include the monitoring of the following human physiological parameters: ECG waveform derived from 3, 5, 6 and 12 lead measurements Heart Rate Pulse Oximetry (Sp02) ST Segment Analysis Arrhythmia Detection Non Invasive Blood Pressure (NIBP) Invasive Blood Pressure (IBP) Cardiac Output (CO) Respiratory Gasses Respiration Rate Temperature The V Series Monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices. Recall # Z-1102-2012

510 K - K102004 P/N and Serial Numbers 0998-00-1800-101 EGK16006559 0998-00-1800-101 EGK16006562 0998-00-1800-101 EGK16006590 0998-00-1800-101 EGK16006601 0998-00-1800-101 EGK16006628 0998-00-1800-101 EGK16006633 0998-00-1800-101 EGK17006943 0998-00-1800-101 EGK13004267 0998-00-1800-101 EGK13004271 0998-00-1800-101 EGK13004302 0998-00-1800-101 EGK13004303 0998-00-1800-101 EGK13004307 0998-00-1800-101 EGK14005442 0998-00-1800-101 EGK14005446 0998-00-1800-101 EGK14005447 0998-00-1800-101 EGK14005450 0998-00-1800-101 EGK14005454 0998-00-1800-101 EGK14005455 0998-00-1800-101 EGK14005462 0998-00-1800-101 EGK14005480 0998-00-1800-101 EGK14005485 0998-00-1800-101 EGK14005503 0998-00-1800-101 EGK15006285 0998-00-1800-101 EGK15006288 0998-00-1800-101 EGK15006297 0998-00-1800-101 EGK15006299 0998-00-1800-101 EGK15006302 0998-00-1800-201 EGN14005560 0998-00-1800-201 EGN14005889 0998-00-1800-101 EG-08000821 0998-00-1800-101 EG-09001590 0998-00-1800-101 EG-09001600 0998-00-1800-101 EG-09001610 0998-00-1800-101 EG-09001612 0998-00-1800-101 EG-09001617 0998-00-1800-101 EG-09001621 0998-00-1800-101 EG-0B002492 0998-00-1800-101 EGK11002620 0998-00-1800-101 EGK12002944 0998-00-1800-101 EGK12002945 0998-00-1800-101 EGK12002967 0998-00-1800-101 EGK12002990 0998-00-1800-101 EGK12002992 0998-00-1800-101 EGK13003806 0998-00-1800-101 EGK13003825 0998-00-1800-101 EGK13003834 0998-00-1800-101 EGK13003854 0998-00-1800-101 EGK13004293 0998-00-1800-101 EGK14005464 0998-00-1800-101 EGK14005909 0998-00-1800-101 EGK14005917 0998-00-1800-101 EGK14005919 0998-00-1800-201 EGN12002923 0998-00-1800-201 EGN12002927 0998-00-1800-201 EGN13003759 0998-00-1800-201 EGN13003764 0998-00-1800-201 EGN13003768 0998-00-1800-201 EGN13003791 0998-00-1800-201 EGN13003795 0998-00-1800-201 EGN13003797 0998-00-1800-201 EGN14005529 0998-00-1800-101 EGK13004251 0998-00-1800-101 EGK13004259 0998-00-1800-101 EGK13004263 0998-00-1800-101 EGK13004280 0998-00-1800-101 EGK13004285 0998-00-1800-101 EGK14005436 0998-00-1800-101 EGK14005437 0998-00-1800-101 EGK14005484 0998-00-1800-101 EGK14005912 0998-00-1800-101 EGK15006292 0998-00-1800-101 EGK15006295 0998-00-1800-101 EGK15006303 0998-00-1800-101 EGK17007607 0998-00-1800-201 EGN14005522 0998-00-1800-201 EGN11002574 0998-00-1800-201 EGN11002578 0998-00-1800-201 EGN11002584 0998-00-1800-201 EGN11002588 0998-00-1800-201 EGN13004514 0998-00-1800-201 EGN13004518 0998-00-1800-201 EGN13004532 0998-00-1800-201 EGN13004544 0998-00-1800-201 EGN13004560 0998-00-1800-201 EGN14005514 0998-00-1800-201 EGN14005518 0998-00-1800-201 EGN14005530 0998-00-1800-201 EGN14005555 0998-00-1800-201 EGN14005895 0998-00-1800-201 EGN13004537 0998-00-1800-201 EGN13004561 0998-00-1800-201 EGN14005875 0998-00-1800-201 EGN14005877 0998-00-1800-201 EGN14005878 0998-00-1800-201 EGN14005897 0998-00-1800-101 EG-08000768 0998-00-1800-101 EG-08000769 0998-00-1800-101 EG-08000771 0998-00-1800-101 EG-08000774 0998-00-1800-101 EG-08000775 0998-00-1800-101 EG-08000776 0998-00-1800-101 EG-08000779 0998-00-1800-101 EG-08000780 0998-00-1800-101 EG-08000783 0998-00-1800-101 EG-08000785 0998-00-1800-101 EG-08000787 0998-00-1800-101 EG-08000788 0998-00-1800-101 EG-08000789 0998-00-1800-101 EG-08000790 0998-00-1800-101 EG-08000791 0998-00-1800-101 EG-08000792 0998-00-1800-101 EG-08000793 0998-00-1800-101 EG-08000794 0998-00-1800-101 EG-08000795 0998-00-1800-101 EG-08000796 0998-00-1800-101 EG-08000797 0998-00-1800-101 EG-08000801 0998-00-1800-101 EG-08000802 0998-00-1800-101 EG-08000804 0998-00-1800-101 EG-08000805 0998-00-1800-101 EG-08000807 0998-00-1800-101 EG-08000808 0998-00-1800-101 EG-08000809 0998-00-1800-101 EG-08000810 0998-00-1800-101 EG-08000814 0998-00-1800-101 EG-08000815 0998-00-1800-101 EG-08000818 0998-00-1800-101 EG-08000819 0998-00-1800-101 EG-08000820 0998-00-1800-101 EG-08000822 0998-00-1800-101 EG-08000824 0998-00-1800-101 EG-09001572 0998-00-1800-101 EG-09001573 0998-00-1800-101 EG-09001574 0998-00-1800-101 EG-09001575 0998-00-1800-101 EG-09001576 0998-00-1800-101 EG-09001577 0998-00-1800-101 EG-09001578 0998-00-1800-101 EG-09001580 0998-00-1800-101 EG-09001581 0998-00-1800-101 EG-09001582 0998-00-1800-101 EG-09001583 0998-00-1800-101 EG-09001584 0998-00-1800-101 EG-09001585 0998-00-1800-101 EG-09001586 0998-00-1800-101 EG-09001587 0998-00-1800-101 EG-09001588 0998-00-1800-101 EG-09001589 0998-00-1800-101 EG-09001591 0998-00-1800-101 EG-09001592 0998-00-1800-101 EG-09001593 0998-00-1800-101 EG-09001594 0998-00-1800-101 EG-09001595 0998-00-1800-101 EG-09001597 0998-00-1800-101 EG-09001598 0998-00-1800-101 EG-09001599 0998-00-1800-101 EG-09001602 0998-00-1800-101 EG-09001603 0998-00-1800-101 EG-09001605 0998-00-1800-101 EG-09001606 0998-00-1800-101 EG-09001607 0998-00-1800-101 EG-09001608 0998-00-1800-101 EG-09001609 0998-00-1800-101 EG-09001611 0998-00-1800-101 EG-09001613 0998-00-1800-101 EG-09001614 0998-00-1800-101 EG-09001615 0998-00-1800-101 EG-09001618 0998-00-1800-101 EG-09001620 0998-00-1800-101 EG-09001622 0998-00-1800-101 EG-09001623 0998-00-1800-101 EG-09001624 0998-00-1800-101 EG-09001626 0998-00-1800-101 EG-09001627 0998-00-1800-101 EG-0B002485 0998-00-1800-101 EG-0B002487 0998-00-1800-101 EG-0B002488 0998-00-1800-101 EG-0B002489 0998-00-1800-101 EG-0B002493 0998-00-1800-101 EG-0B002494 0998-00-1800-101 EG-0B002496 0998-00-1800-101 EG-0B002497 0998-00-1800-101 EG-0B002501 0998-00-1800-101 EGK0C002568 0998-00-1800-101 EGK11002608 0998-00-1800-101 EGK11002610 0998-00-1800-101 EGK11002611 0998-00-1800-101 EGK11002614 0998-00-1800-101 EGK11002616 0998-00-1800-101 EGK11002624 0998-00-1800-101 EGK11002629 0998-00-1800-101 EGK11002631 0998-00-1800-101 EGK11002632 0998-00-1800-101 EGK11002633 0998-00-1800-101 EGK12002941 0998-00-1800-101 EGK12002942 0998-00-1800-101 EGK12002943 0998-00-1800-101 EGK12002946 0998-00-1800-101 EGK12002947 0998-00-1800-101 EGK12002948 0998-00-1800-101 EGK12002949 0998-00-1800-101 EGK12002950 0998-00-1800-101 EGK12002952 0998-00-1800-101 EGK12002953 0998-00-1800-101 EGK12002954 0998-00-1800-101 EGK12002955 0998-00-1800-101 EGK12002956 0998-00-1800-101 EGK12002957 0998-00-1800-101 EGK12002958 0998-00-1800-101 EGK12002959 0998-00-1800-101 EGK12002960 0998-00-1800-101 EGK12002961 0998-00-1800-101 EGK12002962 0998-00-1800-101 EGK12002963 0998-00-1800-101 EGK12002964 0998-00-1800-101 EGK12002965 0998-00-1800-101 EGK12002966 0998-00-1800-101 EGK12002968 0998-00-1800-101 EGK12002969 0998-00-1800-101 EGK12002970 0998-00-1800-101 EGK12002971 0998-00-1800-101 EGK12002972 0998-00-1800-101 EGK12002973 0998-00-1800-101 EGK12002974 0998-00-1800-101 EGK12002975 0998-00-1800-101 EGK12002976 0998-00-1800-101 EGK12002977 0998-00-1800-101 EGK12002978 0998-00-1800-101 EGK12002979 0998-00-1800-101 EGK12002980 0998-00-1800-101 EGK12002981 0998-00-1800-101 EGK12002982 0998-00-1800-101 EGK12002983 0998-00-1800-101 EGK12002984 0998-00-1800-101 EGK12002985 0998-00-1800-101 EGK12002986 0998-00-1800-101 EGK12002987 0998-00-1800-101 EGK12002988 0998-00-1800-101 EGK12002989 0998-00-1800-101 EGK12002991 0998-00-1800-101 EGK12002993 0998-00-1800-101 EGK13003807 0998-00-1800-101 EGK13003808 0998-00-1800-101 EGK13003809 0998-00-1800-101 EGK13003810 0998-00-1800-101 EGK13003811 0998-00-1800-101 EGK13003812 0998-00-1800-101 EGK13003813 0998-00-1800-101 EGK13003814 0998-00-1800-101 EGK13003815 0998-00-1800-101 EGK13003816 0998-00-1800-101 EGK13003817 0998-00-1800-101 EGK13003818 0998-00-1800-101 EGK13003819 0998-00-1800-101 EGK13003820 0998-00-1800-101 EGK13003821 0998-00-1800-101 EGK13003822 0998-00-1800-101 EGK13003823 0998-00-1800-101 EGK13003826 0998-00-1800-101 EGK13003827 0998-00-1800-101 EGK13003828 0998-00-1800-101 EGK13003829 0998-00-1800-101 EGK13003830 0998-00-1800-101 EGK13003831 0998-00-1800-101 EGK13003832 0998-00-1800-101 EGK13003833 0998-00-1800-101 EGK13003835 0998-00-1800-101 EGK13003836 0998-00-1800-101 EGK13003837 0998-00-1800-101 EGK13003838 0998-00-1800-101 EGK13003839 0998-00-1800-101 EGK13003840 0998-00-1800-101 EGK13003841 0998-00-1800-101 EGK13003842 0998-00-1800-101 EGK13003843 0998-00-1800-101 EGK13003844 0998-00-1800-101 EGK13003845 0998-00-1800-101 EGK13003846 0998-00-1800-101 EGK13003847 0998-00-1800-101 EGK13003848 0998-00-1800-101 EGK13003849 0998-00-1800-101 EGK13003851 0998-00-1800-101 EGK13003852 0998-00-1800-101 EGK13003853 0998-00-1800-101 EGK13003855 0998-00-1800-101 EGK13003856 0998-00-1800-101 EGK13003857 0998-00-1800-201 EG-08000729 0998-00-1800-201 EG-08000733 0998-00-1800-201 EG-08000737 0998-00-1800-201 EG-08000738 0998-00-1800-201 EG-08000746 0998-00-1800-201 EG-08000748 0998-00-1800-201 EG-08000750 0998-00-1800-201 EG-08000753 0998-00-1800-201 EG-08000759 0998-00-1800-201 EG-08000760 0998-00-1800-201 EG-08000764 0998-00-1800-201 EG-08000765 0998-00-1800-201 EG-09001826 0998-00-1800-201 EG-09001828 0998-00-1800-201 EG-09001831 0998-00-1800-201 EG-09001832 0998-00-1800-201 EG-09001834 0998-00-1800-201 EG-09001836 0998-00-1800-201 EG-09001840 0998-00-1800-201 EG-09001844 0998-00-1800-201 EG-09001845 0998-00-1800-201 EG-09001846 0998-00-1800-201 EG-09001847 0998-00-1800-201 EG-09001848 0998-00-1800-201 EG-09001852 0998-00-1800-201 EGN11002570 0998-00-1800-201 EGN11002571 0998-00-1800-201 EGN11002573 0998-00-1800-201 EGN11002576 0998-00-1800-201 EGN11002577 0998-00-1800-201 EGN11002579 0998-00-1800-201 EGN11002581 0998-00-1800-201 EGN11002582 0998-00-1800-201 EGN11002585 0998-00-1800-201 EGN11002586 0998-00-1800-201 EGN11002591 0998-00-1800-201 EGN11002593 0998-00-1800-201 EGN11002595 0998-00-1800-201 EGN11002597 0998-00-1800-201 EGN11002598 0998-00-1800-201 EGN12002884 0998-00-1800-201 EGN12002885 0998-00-1800-201 EGN12002886 0998-00-1800-201 EGN12002887 0998-00-1800-201 EGN12002888 0998-00-1800-201 EGN12002889 0998-00-1800-201 EGN12002890 0998-00-1800-201 EGN12002891 0998-00-1800-201 EGN12002892 0998-00-1800-201 EGN12002893 0998-00-1800-201 EGN12002894 0998-00-1800-201 EGN12002896 0998-00-1800-201 EGN12002899 0998-00-1800-201 EGN12002900 0998-00-1800-201 EGN12002901 0998-00-1800-201 EGN12002902 0998-00-1800-201 EGN12002903 0998-00-1800-201 EGN12002904 0998-00-1800-201 EGN12002906 0998-00-1800-201 EGN12002907 0998-00-1800-201 EGN12002908 0998-00-1800-201 EGN12002909 0998-00-1800-201 EGN12002910 0998-00-1800-201 EGN12002912 0998-00-1800-201 EGN12002914 0998-00-1800-201 EGN12002916 0998-00-1800-201 EGN12002917 0998-00-1800-201 EGN12002918 0998-00-1800-201 EGN12002920 0998-00-1800-201 EGN12002921 0998-00-1800-201 EGN12002922 0998-00-1800-201 EGN12002924 0998-00-1800-201 EGN12002925 0998-00-1800-201 EGN12002926 0998-00-1800-201 EGN12002928 0998-00-1800-201 EGN12002929 0998-00-1800-201 EGN12002930 0998-00-1800-201 EGN12002931 0998-00-1800-201 EGN12002932 0998-00-1800-201 EGN12002933 0998-00-1800-201 EGN12002934 0998-00-1800-201 EGN12002936 0998-00-1800-201 EGN12002938 0998-00-1800-201 EGN12002940 0998-00-1800-201 EGN13003760 0998-00-1800-201 EGN13003761 0998-00-1800-201 EGN13003762 0998-00-1800-201 EGN13003765 0998-00-1800-201 EGN13003767 0998-00-1800-201 EGN13003769 0998-00-1800-201 EGN13003770 0998-00-1800-201 EGN13003771 0998-00-1800-201 EGN13003772 0998-00-1800-201 EGN13003773 0998-00-1800-201 EGN13003774 0998-00-1800-201 EGN13003775 0998-00-1800-201 EGN13003776 0998-00-1800-201 EGN13003778 0998-00-1800-201 EGN13003779 0998-00-1800-201 EGN13003780 0998-00-1800-201 EGN13003781 0998-00-1800-201 EGN13003782 0998-00-1800-201 EGN13003783 0998-00-1800-201 EGN13003784 0998-00-1800-201 EGN13003785 0998-00-1800-201 EGN13003786 0998-00-1800-201 EGN13003788 0998-00-1800-201 EGN13003789 0998-00-1800-201 EGN13003790 0998-00-1800-201 EGN13003792 0998-00-1800-201 EGN13003793 0998-00-1800-201 EGN13003794 0998-00-1800-201 EGN13003796 0998-00-1800-201 EGN13003798 0998-00-1800-201 EGN13003799 0998-00-1800-201 EGN13003800 0998-00-1800-201 EGN13003801 0998-00-1800-201 EGN13003803 0998-00-1800-201 EGN13003805 0998-00-1800-201 EGN13003755 0998-00-1800-201 EGN13004513 0998-00-1800-201 EGN13004516 0998-00-1800-201 EGN13004519 0998-00-1800-201 EGN13004520 0998-00-1800-201 EGN13004525 0998-00-1800-201 EGN13004531 0998-00-1800-201 EGN13004534 0998-00-1800-201 EGN13004549 0998-00-1800-201 EGN13004558 0998-00-1800-201 EGN14005512 0998-00-1800-201 EGN14005516 0998-00-1800-201 EGN14005520 0998-00-1800-201 EGN14005523 0998-00-1800-201 EGN14005528 0998-00-1800-201 EGN14005532 0998-00-1800-201 EGN14005551 0998-00-1800-201 EGN14005554 0998-00-1800-201 EGN14005558 0998-00-1800-201 EGN14005562 0998-00-1800-201 EGN14005874 0998-00-1800-201 EGN14005882 0998-00-1800-201 EGN14005888 0998-00-1800-201 EGN14005890 0998-00-1800-101 EG-08000767 0998-00-1800-101 EGK14005491 0998-00-1800-101 EGK13004289 0998-00-1800-101 EGK14005434 0998-00-1800-101 EGK14005479 0998-00-1800-201 EG-08000740 0998-00-1800-201 EG-08000766 0998-00-1800-201 EG-09001825 0998-00-1800-201 EG-09001830 0998-00-1800-201 EG-09001838 0998-00-1800-201 EG-09001839 0998-00-1800-201 EG-09001843 0998-00-1800-201 EG-09001849 0998-00-1800-201 EGN13003756 0998-00-1800-201 EGN13003763 0998-00-1800-201 EGN13003802 0998-00-1800-201 EGN13004557 0998-00-1800-201 EGN14005513 0998-00-1800-201 EGN14005525 0998-00-1800-201 EGN14005543 0998-00-1800-201 EGN14005891 0998-00-1800-101 EGK14005490 0998-00-1800-201 EGN14005540 0998-00-1800-101 EGK13004250 0998-00-1800-101 EGK13004252 0998-00-1800-101 EGK13004258 0998-00-1800-101 EGK13004261 0998-00-1800-101 EGK13004262 0998-00-1800-101 EGK13004264 0998-00-1800-101 EGK13004270 0998-00-1800-101 EGK13004272 0998-00-1800-101 EGK13004276 0998-00-1800-101 EGK13004278 0998-00-1800-101 EGK13004282 0998-00-1800-101 EGK13004283 0998-00-1800-101 EGK13004286 0998-00-1800-101 EGK13004287 0998-00-1800-101 EGK13004294 0998-00-1800-101 EGK13004296 0998-00-1800-101 EGK13004298 0998-00-1800-101 EGK13004299 0998-00-1800-101 EGK13004301 0998-00-1800-101 EGK14005453 0998-00-1800-101 EGK14005457 0998-00-1800-101 EGK14005458 0998-00-1800-101 EGK14005459 0998-00-1800-101 EGK14005463 0998-00-1800-101 EGK14005467 0998-00-1800-101 EGK14005472 0998-00-1800-101 EGK14005482 0998-00-1800-101 EGK14005486 0998-00-1800-101 EGK14005488 0998-00-1800-101 EGK14005496 0998-00-1800-101 EGK14005899 0998-00-1800-101 EGK14005903 0998-00-1800-101 EGK14005907 0998-00-1800-101 EGK15006284 0998-00-1800-101 EGK15006286 0998-00-1800-101 EGK15006287 0998-00-1800-101 EGK15006289 0998-00-1800-101 EGK15006291 0998-00-1800-101 EGK15006293 0998-00-1800-101 EGK15006294 0998-00-1800-101 EGK15006300 0998-00-1800-101 EGK15006301 0998-00-1800-201 EG-08000742 0998-00-1800-201 EG-09001827 0998-00-1800-201 EG-09001851 0998-00-1800-201 EG-09001853 0998-00-1800-201 EGN12002905 0998-00-1800-201 EGN13003752 0998-00-1800-201 EGN13003753 0998-00-1800-201 EGN13003757 0998-00-1800-201 EGN13003758 0998-00-1800-201 EGN13003777 0998-00-1800-201 EGN13003787 0998-00-1800-201 EGN13004517 0998-00-1800-201 EGN13004538 0998-00-1800-201 EGN13004554 0998-00-1800-201 EGN13004555 0998-00-1800-201 EGN13004556 0998-00-1800-201 EGN14005508 0998-00-1800-201 EGN14005521 0998-00-1800-201 EGN14005524 0998-00-1800-201 EGN14005548 0998-00-1800-201 EGN14005552 0998-00-1800-201 EGN14005556 0998-00-1800-201 EGN14005559 0998-00-1800-201 EGN14005561 0998-00-1800-201 EGN14005871 0998-00-1800-201 EGN14005872 0998-00-1800-201 EGN14005879 0998-00-1800-201 EGN14005880 0998-00-1800-201 EGN14005881 0998-00-1800-201 EGN14005886 0998-00-1800-201 EGN14005887 0998-00-1800-201 EGN14005894 0998-00-1800-201 EGN14005898 0998-00-1800-101 EGK14005435 0998-00-1800-101 EGK14005451 0998-00-1800-101 EGK14005456 0998-00-1800-101 EGK14005468 0998-00-1800-101 EGK14005470 0998-00-1800-101 EGK14005494 0998-00-1800-101 EGK14005495 0998-00-1800-101 EGK14005500 0998-00-1800-101 EGK14005505 0998-00-1800-101 EGK14005905 0998-00-1800-201 EGN13004515 0998-00-1800-201 EGN14005535 0998-00-1800-201 EGN14005539 0998-00-1800-201 EGN14005883

Mindray DS USA, Inc. d.b.a. Mindray North America, Mahwah, NJ, by letter dated October 14, 2011 on October 17, 2011. Firm Initiated recall is ongoing.

A system database corruption may occur that causes the V Series Monitor to reset.

542 units US; 153 units international

Nationwide, Australia, Chile, Columbia, United Kingdom, and Venezuela

Sunrise Medical Zippie TS wheelchair To empower physically challenged person by providing a means or mobility. Model number: E1Z1A. Recall # Z-1103-2012

Serial number: Z1SE-006474

Sunrise Medical (US) LLC, Fresno, CA, by telephone on January 17, 2012 and by visit on January 18, 2012. Firm initiated recall is complete.

One Zippie TS Wheelchair was made per customer order was shipped with transit brackets for use a seat in a motor vehicle, however the chair was not configured with a back tested seat for motor vehicle use.

1 unit

OK

Presource Custom Sterile Surgical and Procedure Kits containing Ethicon Ethilon Black Nylon Nonabsorbable Surgical Sutures in new Tyvek packaging; surgical trays; The kits are custom packed with all of the specific disposable class 1 and 2 devices required by the customer for specific types of surgery and medical procedures. These packs are then ethylene oxides sterilized and are ready to be used by the customer for the specific procedure. The kits are custom packed with all of the specific disposable class 1 and 2 devices required by the customer for specific types of surgery and medical procedures. These packs are then ethylene oxide sterilized and are ready to be used by the customer for the specific procedure. Catalog numbers PC23OHCTF, PC40OH80J, PC40OH811, PC44GCCMB, PCCGOHEZD, PCOCOHC11, PCOCOHCVT, PE63EMGHB, PE8ATHCSA, PG21OTSYB, PG22CRBRB, PGOCMJSFA, PGVMTOBL4, PGVMTOBL5, PGVMTOBLP, PGW1GSBLM, PGW1OBMUN, PHOCTHMTG, PJ35IVSBA, PN08CRGHA, PN13CRMGC, PNOCCY09I, PO08SAGH3, PO08SAGHM, PO15HATRB, PO41EXCAK, PO41KSCA3, PO41KSCAM, PO42KNTM5, PO42KNTME, PO42KNTMF, PO42SATM2, PO42SATMF, PO42SATMG, PO45ARSJV, PO45UASJMO, PO60ARLHW, PO60SHLHQ, POCGAAMJN, POCGAKJCB, POCGASJCA, PODKLVSTH, PODKPSSTH, POHBAAVAE, POOCARHTN, POOCARHTO, POOCSHEEM, POVMFABHE, POW1AKWMK, PU8ARLCSA, PVOCAAAWPK, PVV1OTGSN, SAN11PTLH1, SAN13INMTM, SAN19PIVAA, SAN19SBFMF, SAN23PLMU3, SAN23PLMU4, SAN23PLMUG, SAN23PLMUH, SAN23PLNCE, SAN30LHTGB, SAN34CIAVH, SAN34FSAVF, SAN44PITCO, SAN49PTMBF, SAN49PTMBG, SAN51INUCH, SAN56PIIHJ, SAN56RPIHG, SAN59DRTCG, SAN69SPWWI, SAN8FMAUAE, SAN8FMAUAF, SANCGPCAUB, SANCGPCAUC, SANW1CIHFA, SBA11TEWHF, SBA11THMME, SBA12LPHEB, SBA13BRLOG, SBA13RPBWD, SBA22BADRT, SBA23CTMUC, SBA23LBSGB, SBA34URMTE, SBA51CAEBG, SBA57UAOHG, SBA69CRSNB, SBA69HPCIK, SBA69PEWWI, SBA8FGRGMA, SBAOCBBASE, SCV11BORJP, SCV31PICMA, SCV33OHSM6, SCV73BHHGH, SCV7CVAGR1, SCV7CVAGRE, SEN41RNSUH, SER11LCCHD, SER11LCCHE, SLC12LPUVN, SNE11CANSN, SNE12CRKGA, SNE23SSRCL, SNE36CRWVL, SNE69VPWWF, SNU49CLM01, SNU49CLMBT, SOP11APIHD, SOP11ARHTI, SOP11ARJMP, SOP11ARNUK, SOP11ARPHI, SOP11ARWAC, SOP11RALHM, SOP11SHEEH, SOP11SHLHH, SOP11SHNUG, SOP13ARCYM, SOP13ARMSN, SOP13ARSHF, SOP13FFBI2, SOP13FTAKH, SOP13HAMEA, SOP13HNSFC, SOP13MAAKF, SOP13MOMHD, SOP13SAMSO, SOP13SHSFC, SOP14ARLM1, SOP14ARLMD, SOP18KNCOJ, SOP18SHCOH, SOP19ARMLK, SOP19KAVAI, SOP19UEMLF, SOP19UEMLG, SOP21KNSTD, SOP21SHSTC, SOP23ARRGC, SOP23SHCTB, SOP23SHCTC, SOP23SPCMB, SOP24ARJHA, SOP24HAOZA, SOP24KPOZB, SOP24SHJHA, SOP24SHOZB, SOP25ACCHF, SOP25ARVAF, SOP25SHCHG, SOP26HDSHF, SOP2RAROSB, SOP2RSPMB3, SOP2RSPMBD, SOP2RSPOSA, SOP31ARWSM, SOP32ARRVG, SOP32CTMCF, SOP32OHTRK, SOP33ARVDK, SOP33KADWI, SOP34HABSE, SOP34KAWSG, SOP35HNJWP, SOP35KAJWP, SOP35PHJWP, SOP35UXJWM, SOP36AKCOJ, SOP36KASUH, SOP40HAPSB, SOP40HPRVB, SOP41ARHGD, SOP41ARSMB, SOP41HNHMK, SOP41KSAGD, SOP41PASUI, SOP41SHAGD, SOP41SHHGB, SOP42BSSKL, SOP42KASKE, SOP42LHSKN, SOP42MCSKG, SOP42RHSKJ, SOP42SASKH, SOP42SHSLB, SOP42SMSKF, SOP42SSSKJ, SOP43KNSUB, SOP43RSMPA, SOP43SHMPB, SOP44ARBBI, SOP44SABBJ, SOP45ACCUE, SOP45ARUVA, SOP45KSCUF, SOP45SAHCB, SOP45SSCUD, SOP48ARHAI, SOP4BKACOF, SOP51HPBJE, SOP53CTOCC, SOP53SPBSD, SOP54ARDYG, SOP55ARWMJ, SOP61PDRHO, SOP63FHKHJ, SOP69CAFCG, SOP69CSFCE, SOP69KAOID, SOP69SHOID, SOP73ACCML, SOP73KACMB, SOPCGAHAUB, SOPCGAHAUC, SOPCGHNBJC, SOPCGKPBJC, SOPCGKPBJD, SOPCNHASDB, SOPHDARSMB, SOPOCHASAB, SOPOCKAASD, SOPOCKALIA, SOPW1SHBOG, SOT30RPVRF, SRH41HTTRB, SRI63LXULE, SRI63UXULF, SRIHT0861N and SRIOR0730S. Recall # Z-1104-2012

All recent lots

Recalling Firm: Cardinal Health, Mc Gaw Park, IL, by letter dated January 26, 2012.

Manufacturers: Cardinal Health, Mc Gaw Park, IL;

Cardinal Health 200, LLC, Fort Mill, SC. Firm initiated recall is ongoing.

The Presource kits were assembled with Ethicon Sutures in new Tyvek packaging which could no longer be placed in kits that will undergo ethylene oxide sterilization.

18,300 kits

Nationwide and Canada

1) Premier LifeCare Recliner 5400. Brochure is labeled in part: "***Premier LifeCare Recliner 5400***Winco***ISO 9001 2008 Certified***Key Features***Urethane armrests***Fully upholstered***Multiple side-table Options***3-position lockbar*** "No pinch" safety zone***Model No. 540***". Long-term multi-positional recliner. Recall # Z-1105-2012;

 

2) Premier Care Recliner Model 5570. Brochure: "***Premier Care Recliner 5570/5574***Winco***ISO 9001 2008 Certified***Key Features***Urethane armrests***Multiple side-table options***3-position lock-bar*** Fully upholstered***OPTIONAL Heat or Heat & Massage***OPTIONAL LiquiCell***. Long-term multi-positional recliner. Recall #Z-1106-2012

1) Serial No. 540;

2) Serial No. 557

Winco Mfg., LLC, Ocala, FL, by letter dated October 24, 2011. Firm initiated recall is complete.

The Position Lock Pin(s) could potentially fail if exposed to excessive force when the chair is in the Locked Recline position. This failure will result in an inoperable Position Lock Bar feature.

133 chairs

Nationwide and Canada

1) BBL[TM] Lysine Iron Agar, catalog #211363,500 g bottle 2014-03-31. Lysine Iron Agar was developed for use in the differentiation of enteric organisms based on their ability to decarboxylate or dominate lysine and to form hydrogen sulfide. Lysine Iron Agar was developed for the use for differentiation of enteric organisms, in particular Salmonella species due to its ability to decarboxylate or deaminate lysine and form hydrogen sulfide. Recall # Z-1107-2012;

 

2) BBL[TM] Lysine Iron Agar, catalog #211363,500 g bottle 2014-03-31. Lysine Iron Agar was developed for use in the differentiation of enteric organisms based on their ability to decarboxylate or dominate lysine and to form hydrogen sulfide. Lysine Iron Agar was developed for the use for differentiation of enteric organisms, in particular Salmonella species due to its ability to decarboxylate or deaminate lysine and form hydrogen sulfide. Recall # Z-1108-2012;

 

3) BBL[TM] Lysine Iron Agar, catalog #211363, 500 g bottle 2014-03-31. Lysine Iron Agar was developed for use in the differentiation of enteric organisms based on their ability to decarboxylate or dominate lysine and to form hydrogen sulfide. Lysine Iron Agar was developed for the use for differentiation of enteric organisms, in particular Salmonella species due to its ability to decarboxylate or deaminate lysine and form hydrogen sulfide. Recall # Z-1109-2012

1) Lot number 0132356 Exp. 3/31/14;

2) Lot number 0204203 Exp. 3/31/14;

3) Lot number 0238264 Exp. 3/31/14

Becton Dickinson & Co., BD Diagnostic Systems, Sparks, MD, by letter dated January 2012. Firm initiated recall is ongoing.

Lysine Iron Agar may not produce the correct biochemical reactions with Quality Control organisms over the shelf life of the product.

297 bottles

Nationwide and Internationally

1) GE Discovery NM/CT 670 The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM/CT 670 system, combining Nuclear Medicine (NM) and Computed Tomography (CT) systems, is intended to produce: NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. Recall # Z-1110-2012;

 

2) GE Discovery NM 630 The GE Discovery NM 630 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM 630 system is a Nuclear Medicine (NM) system, which is intended to yield General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. Recall # Z-1111-2012

1) Lot # 00ME1 21023 21030 21044 21045 21062 21065 21069 21077 21003 21006 21010 21027 21036 21043 21046 21051 21084 21005 21072 21007 21047 21011 21018 21025 21071 21026 21068 21038 21089 21012 21059 00P3 21031 21004 21014 21053 21024 21021 21022 21033 21035 21037 21063 21064 21067 21070 21073 21086 21009 21019 21055 21028 21052 21076 21083 21048 21061 21058 21001 21008 21034 21050 21056 21002 21013 21017 21020 21029 21039 21041 21066 21075 21079 21080 21081 21082 21016 21040;

 

2) Lot # 22002 22017 22018 22015 22009 22008 22005 22001 22014 22003

Recalling Firm: GE Healthcare, LLC, Waukesha, WI, by letter dated January 13, 2012.

Manufacturer: GE Medical System Israel Ltd, Tirat Hacarmel, Israel. Firm initiated recall is ongoing.

GE Healthcare has recently become aware of a potential safety issue associated with the collimator cart and lead cover of your Discovery NM/CT 670 and/or Discovery NM 630 system that may impact operator safety. 1. The cart locking pin release and cart disengagement could result in the collimator falling down and could lead to operator or service personnel injury. 2. Another issue is that the lead cover handle separation could result in plate swing resulting in potential injury to service personnel.

89 units

Nationwide and Internationally

Perkin Elmer Genetic Screening Processor (GSP) Product code: 2021-0010. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids. Recall # Z-1116-2012

Serial numbers from 20210012 to 20210021.

PerkinElmer Life and Analytical Sciences, Wallac, OY, Turku, Finland. Firm initiated recall is ongoing.

GSP instruments with defective washer modules may cause a false negative screening result being reported for T4, TSH and IRT. For 17-OHP, a false positive result may be generated if the failure occurs for a normal sample.

10 units

Nationwide and Internationally

VITROS Chemistry Products PHBR Slides, REF 822 1384 --- COMMON/USUAL NAME: VITROS PHBR (Phenobarbital) Slides. This is an in vitro diagnostic. For in vitro diagnostic use only. VITROS Chemistry Products PHBR Slides quantitatively measure Phenobarbital (PHBR) concentration in serum and plasma using VITROS 250/350/950 and 5,1 FS Chemistry Systems and the VITROS 5600 Integrated System. Recall # Z-1117-2012

Lot numbers: 2532-0053-4961 (exp. 2/01/12), 2532-0053-4984 (exp. 2/01/12), 2532-0053-4996 (exp. 3/01/12), 2532-0053-4997 (exp. 3/01/12), 2532-0053-0144 (exp. 3/01/12), 2532-0053-0149 (exp. 3/01/12), 2532-0053-0217 (exp. 3/01/12), 2532-0053-0615 (exp. 4/01/12), 2532-0053-0616 (exp. 4/01/12), 2532-0053-1472 (exp. 5/01/12), 2532-0053-1488 (exp. 5/01/12), 2532-0053-1489 (exp. 5/01/12), 2532-0053-1490 (exp. 5/01/12) [Note the four middle numbers (0053) of the above Lot #s constitute the Coating #].

Ortho-Clinical Diagnostics, Rochester, NY, by letter dated June 23, 2011. Firm initiated recall is ongoing.

Ortho Clinical Diagnostics (OCD) received customer complaints of intermittent imprecision, outliers, or shifts in control fluid values when using various lots of VITROS Chemistry Products PHBR Slides (Phenobarbital) from Coating 0053.

Nationwide 2345 units, Internationally 632 units

Nationwide and Internationally

Product Brand Names: Triage Drugs of Abuse Panel 8 Test Kit (K924476), Triage Drugs of Abuse Panel Plus TCA (K973784), & Triage Drugs of Abuse Panel Plus PPX (K014247) Model Number: a) 90008, b) 92002, and c) 92000 Type of Packaging (i.e. box, plastic bag): For all affected device types: 25 individually pouched devices in a labeled kit box. The Triage Drugs of Abuse Panel plus Tricyclic Antidepressants utilizes a patented immunochemistry, ASCENDTM MULTIMMUNOASSAY (AMIATM). Each AMIATM assay is a competitive binding immunoassay in which a chemically labeled drug (drug conjugate) competes with drug which may be present in the urine for antibody binding sites. After a brief incubation, the reaction mixture is transferred to the membrane in the Detection Area. Free drug conjugate that is displaced from antibody binding sites by drug in the urine, binds to a zone of monoclonal antibody that is immobilized on the membrane. The membrane is washed to remove the unbound conjugate and clear the background. Test results are visually read. The Triage Drugs of Abuse Panel plus Tricyclic Antidepressants is an immunoassay used for the qualitative determination of the presence of the major metabolites of drugs of abuse, (Phencyclidine, Benzodiazepines, Cocaine Metabolite, Amphetamines, THC, Opiates, Barbiturates), and Tricyclic Antidepressants in urine. Recall # Z-1130-2012

a) Lot 259403 exp 02/03/13, lot 267081 exp 05/08/13; b) lot 234295 exp 02/03/13; c) lots 254662, 255830, 257527, 262143 with exp 01/06/13; lots 259628, 259954 with exp 02/03/13

Alere San Diego, San Diego, CA, by letter dated January 4, 2012. Firm initiated recall is ongoing.

Alere San Diego received a rise in customer complaints regarding false positive Barbiturates (BAR) results on the Triage Drugs of Abuse Panel Plus TCA.

693,054 kits

Nationwide, Australia, Brazil, Canada, EU, Guatemala, Japan, Lebanon, and Saudi Arabia

Philips IntelliVue Patient Monitors: T The monitor is intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates in health care facilities. The monitor is to be used by trained health care professionals. Physiological Monitoring, Patient Monitor, Arrhythmia detector and alarm (including ST -segment measurement and alarm. MP20 (M8001A), MP30 (M8002A), MP40 (M8003A), MP50 (M8004A), MP60 (M8005A), MP70 (M8007A), MP80 (M8008A), MP90 (M8010A), D80 (M8016A), MX600 (865242), MX700 (865241) MX800 (865240). Recall # Z-1134-2012

Models with SW Revision H (up to and including H.15.36) are affected, upgraded between October 6, 2010 and January 23, 2012

Recalling Firm: Philips Healthcare Inc., Andover, MA, by letter dated February 7, 2012.

Manufacturer: Philips Medizin Systeme Boblingen Gmbh, Boblingen, Germany. Firm Initiated recall is ongoing.

Central station monitors may not alarm (either visual or audible) when an alarm is announced at the affected patient monitor.

83,534 units

Nationwide and Internationally

Boston Scientific, LATITUDE Patient Management System Communicator, Models 6476. The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Guidant or Boston Scientific pulse generator and transfer data to a central database. Recall # Z-1135-2012

SN 224453

Boston Scientific CRM Corp., Saint Paul, MN, by telephoned on January 19, 2012. Firm initiated recall is ongoing.

One (1) Model 6476 LATITUDE Communicator is unable to interrogate the patient's pulse generator. Boston Scientific has determined that this is due to a patient receiving an incorrect communicator. Therefore the communicator did not find and was unable to interrogate the assigned patients PG. Additionally when the patient attempted to set-up this incorrect communicator, the system reflected a monitor status for the assigned patient. No patient deaths or injuries have been associated with this communicator behavior.

1 unit

UT

REF 42-422561 SIGNATURE QTY, 1 TKA GDE/MDL (Prosthesis, knee) SET 04-05 DGHUMPHR-NOV52LKA-J_K-00432022 SLIDEX DISTAL-MP/PREMIER TIBIAL CUSTOM-MADE DEVICE Signature Personalized Patient Care System is intended to be used as a surgical instrument to assist in the positioning of total and partial knee replacement components intra-operatively and in the guiding and marking of bone before cutting and to guide cutting, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. Recall # Z-1145-2012

Lot numbers: 025565 & 025640

Biomet, Inc., Warsaw, IN, by letter dated January 23, 2012. Firm initiated recall is ongoing.

(2) specific lots of part number 42-422561 were incorrectly labeled. One (1) unit (lot 025640) was received back from distributor's office as a product complaint.

2 units

VA, OH

1) Synchron Phenobarbital (PHE) Drug Calibrator 1, P/N 469600, Classification Product Code: KLT. Subsequent Product Codes: DIP, KLS, LCD, LCQ, LCR, LFN. The Beckman Coulter SYNCHRON Systems DRUG CALIBRATOR 1, when used in conjunction with SYNCHRON reagents, is intended for use on the SYNCHRON Systems for the calibration of Carbamazepine, Phenobarbital, Phenytoin, Theophylline, and Valproic Acid. Recall # Z-1173-2012;

 

2) Synchron Phenobarbital (PHE) Reagent, P/N 469785, Classification Product Code: KLT. Subsequent Product Codes: DIP, KLS, LCD, LCQ, LCR, LFN. PHE reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems Drug Calibrator 1, is intended for quantitative determination of Phenobarbital concentration in human serum or plasma. Recall # Z-1174-2012

1) M810440 and earlier;

2) M810083 and earlier

letter dated August 26, 2009. Firm initiated recall is ongoing.

Reports of variability in results with the lots of Phenobarbital (PHE) reagent and calibrator.

110,144 units

Nationwide and Canada

Siemens mMLC (ModuLeaf) safety bar and trolley label. The intended use of the Siemens branded mMLC is an accessory used with the Linear Accelerator systems to deliver x-ray photon and electron radiation for the therapeutic treatment of cancer. This accessory shapes the radiation beam, per the leaf parameters, to minimize the amount of dose to outlying tissue. ModuLeaf, part number 7334043; ModuLeaf, part number 7334050. Recall # Z-1184-2012

110V/60Hz; 220V/60Hz

Recalling Firm: Siemens Medical Solutions USA, Inc., Concord, CA. by letter on February 7, 2012.

Manufacturer: Siemens Ag Medical Solutions, Kemnath, Germany. Firm initiated recall is ongoing.

This correction is being performed to update the safety know of the Siemens brand mMLC (ModuLeaf) to conform to tie IEC 60601-1 safety standard.

46 active devices

Nationwide and Internationally

1) Left Long Tactile Probe, Part #962009S. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications. Recall # Z-1189-2012;

 

2) Right Long Tactile Probe, Part #962011S. Trackable handheld instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications. Recall # Z-1190-2012

1) Lot Numbers 090106, 090407, 071219;

2) Lot Numbers: 090106, 071219

Medtronic Navigation, Inc., Louisville, CO, by letter on February 6, 2012. Firm initiated recall is ongoing.

When subjected to bending, twisting, and malleting, the probe tips break off when used in the sacrum for which they are not indicated for use. These probes are approved for use in the lumbar vertebra.

11 units

Nationwide and Republic of South Korea

PointCare NOW CD4NOW Gold Reagent Pack, or Gold Pack, Part Number: 30034 In Vitro Diagnostic; Assay reagent intended for use on the PointCare NOW In Vitro Diagnostics Instrument to provide CD4 positive lymphocytes cell count. Recall # Z-1193-2012

Lot Numbers: KG13230, KG13231, KG21520 and KG21521

Pointcare Technologies, Inc., Marlborough, MA, by letter dated November 2, 2011. Firm Initiated recall is complete.

Stability not assured at labeled temperature 2-42 C.

463 packs

Abuja, Haiti, Indonesia, Natal, Nigeria, Senegal, South Africa, Uganda, and UK

 

Children's Medical Ventures 1 ml Amber Oral Syringe. The product is a Liquid Medication Dispenser. Catalog number 1047080. Recall # Z-1070-2012

Lot numbers 076192, 076404, 076904, 077695, 078697, 079540 and 079686.

Recalling Firm: Benlan, Inc., Oakville, Canada, by letter in November, 2011.

Manufacturer: Becton Dickinson Medical Systems, Canaan, CT. Firm initiated recall is ongoing.

The tip caps may come loose from the syringe, potentially resulting in leakage of medication from the syringe.

143,250

Nationwide

LATITUDE Patient management System, Model 6488, software version 7.2. It is indicated for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database. Recall # Z-1096-2012

Software version 7.2

Boston Scientific CRM Corp., Saint Paul, MN, by telephone beginning on December 19, 2011. Firm initiated recall is ongoing.

Patients are not able to perform setup. There is no risk to health associated with this issue.

1 unit

Nationwide

1) Soy Beginnings, Non-GMO Low-Fat Soy Flour, Net Wt. a) 40 lbs bags, Product Code 285100-NFB; and b) 1500 lbs totes, Product Code 285100-NFT; NEEDS TO BE FURTHER PROCESSED. Recall # V-051-2012;

 

2) NexSoy, Certified Non-GMO Low-Fat Soy Flour, Net Wt. 40 lbs bags, NEEDS TO BE FURTHER PROCESSED. Recall # V-052-2012;

 

3) Bulk Soy Meal in .08 ton loads. Recall # V-053-2012

1) a) Lot Numbers: TF102710, TF112210, TF112310 thru TF033011; b) Lot Numbers: TF102610, TF112210, TF112310 thru TF082311;

2) Lot numbers: TF102710, TF112210, and TF112310 thru TF033011;

3) Lot numbers: O011711 thru O081711

Thumb Oilseed Producers' Cooperative, Ubly, MI, by letters on September 15, 2011 and October 4, 2011. Firm initiated recall is ongoing.

The recall resulted from routine sampling programs conducted by the company which revealed salmonella bacteria in the finished product.

3715 (total for both brand names in 40 lb. bags) and 397, 1500 lb. totes of soy flour; and 924 .08 tons of soy meal

VA, CA, IL, VT, MN, PA, NH, UT, WI, OH, Canada, and Japan

 

1) Sterile Water for Injection, USP, packaged in 250-, 500-, and 1,000-mL bottles, 12 bottles/case, packaged under the following labels: (1) AgriLabs Sterile Water for Injection, USP, packaged in 250-mL bottles, NDC 57561-808-25; (2) RXV Products Sterile Water for Injection, packaged in 250- and 1,000-mL bottles; (3) Aspen Veterinary Resources, Ltd. Sterile Water for Injection, USP, packaged in 500-mL (NDC 46066-808-50) and 1,000-mL (NDC 46066-808-60) bottles; (4) Phoenix Sterile Water for Injection, USP, packaged in 250-mL bottles, NDC 57319-546-06; and (5) VEDCO Sterile Water for Injection, packaged in 250-mL bottles, NDC 50989-640-15. Recall # V-054-2012;

 

2) Sterile Saline Solution, each 100 mL contains 0.9g sodium chloride and q.s. water for injection, packaged in 250- and 500-mL bottles, 12 bottles/case, for IV or subcutaneous injection, RX, packaged under the following labels: (1) RXV Products Sterile Saline Solution, packaged in 500-mL bottles; (2) Aspen Veterinary Resources, Ltd. Sterile Saline Solution, packaged in 500-mL bottles, NDC #46066-807-50; (3) VET one Sterile Saline Solution, USP, packaged in 500-mL bottles, NDC 13985-807-50; (4) Butler Schein Animal Health Physiological Saline Solution, packaged in 250- and 500-mL bottles; and (5) VEDCO Normal Saline Solution, packaged in 500-mL bottles, NDC 50989-641-16. Recall # V-055-2012;

 

3) Hypertonic Saline Solution 7.2%, each 100 mL of sterile aqueous solution contains 7.2g sodium chloride, packaged in 1,000-mL bottles, 12 bottles/case, sterile, preservative free, for IV or subcutaneous injection, RX, packaged under the following labels: (1) RXV Products Hypertonic Saline Solution 7.2%; and (2) VetTek Hypertonic Saline Solution 7.2%, NDC 60270-857-20. Recall # V-056-2012;

 

4) Dextrose 50% Injection, each 100 mL contains 50g dextrose monohydrate and q.s. water for injection, packaged in 500-mL bottles, 12 bottles per case, for IV administration only, OTC. The product is packaged under the following labels: (1) AgriLabs Dextrose 50%, NDC 57561-801-50; (2) Phoenix Pharmaceutical, Inc. Dextrose Solution 50%, NDC 57319-543-07; and (3) VET one Dextrose 50% Injection, USP, NDC 13985-067-00. Recall # V-057-2012;

 

5) VET one DextroLyte Injection, Sterile Solution, Electrolytes, Dextrose, each 500 mL of sterile aqueous solution contains 12.50g dextrose monohydrate, 12.50g sorbitol, 3.95g sodium lactate, 2.40g sodium chloride, 0.37g potassium chloride, 0.21g magnesium chloride hexahydrate, and 0.19g calcium chloride dihydrate, packaged in 500-mL bottles, 12 bottles/case, for IV or intraperitoneal injection, RX, NDC 13985-804-05. Recall # V-058-2012;

 

6) Lactated Ringers Solution, each 100 mL contains 600 mg sodium chloride, 310 mg sodium lactate, 30 mg potassium chloride, 20 mg calcium chloride dihydrate, q.s. water for injection, sterile nonpyrogenic solution, packaged in 1000-mL bottles, 12 bottles/case, for IV, subcutaneous, or intraperitoneal injection, RX. Packaged under the following labels: (1) RXV Products Lactated Ringers Injection; and (2) Aspen Veterinary Resources, Ltd. Lactated Ringers Solution, NDC 46066-803-60. Recall # V-059-2012;

 

7) VET one CMPK Solution, Calcium-Magnesium-Phosphorus-Potassium-Dextrose, each 500 mL contains 75.0g dextrose monohydrate, 10.8g calcium (as calcium borogluconate), 8.0g potassium (as potassium chloride), 2.5g phosphorus (as sodium hypophosphite monohydrate), and 1.6g magnesium (as magnesium borogluconate), sterile, packaged in 500-mL bottles, 12 bottles/case, for I.V. use only, RX, NDC 13985-805-50. Recall # V-060-2012

1) 1) Lot #A111007-2; 2) Lot #A111007-1 (250-mL); and Lot #A111011-2 (1,000-mL); 3) Lot #A111014-1 (500-mL) and Lot #A111011-1 (1,000-mL); 4) Lot #B111009-1; Lot #5) A111007-3 and Lot #B111009-2, all with an exp. date of OCT 2013;

 

2) RXV - Lot #A111015-1; Aspen Veterinary Resources, Ltd. - A111015-2; VET one - Lot #A111015-3; Butler Schein 250-mL - B111007-1; Butler Schein 500-mL - A111015-4; and VEDCO - Lot #A111015-5, all with an exp. date of OCT 2013;

 

3) 1) Lot #A111016-1, exp. OCT 2013; and 2) Lot #A111016-2, exp. OCT 2013;

 

4) 1) Lot #A111013-2, exp. OCT 2013; 2) Lot #A111013-1, exp. OCT 2013; and 3) Lot #B111004-1, exp. OCT 2013;

 

5) Lot A111009-1, exp. OCT 2013;

 

6) 1) Lot A111012-1, Exp. OCT 2013; 2) Lot A111012-2, Exp. OCT 2013;

 

7) Lot A111008-1, Exp. OCT 2013

Nova-Tech Inc., Grand Island, NB, by letters dated December 16, 2011. Firm initiated recall is ongoing.

Lack of sterility assurance.

284,952 bottles

MO and ID