Recalling Firm
Community Blood Centers of South Florida, Inc.
American National Red Cross Southeastern Michigan Region
Blood Systems, Inc. dba United Blood Services
Community Blood Centers of Florida, Inc.
Horiba Instruments, Inc dba Horiba Medical
Tri-Union Seafoods, L.L.C dba Chicken of the Sea.

Initial Firm Notification of Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Distribution Pattern
Michigan; Massachusetts; Florida; Louisiana; New York
Worldwide distribution: USA (nationwide) and countries of: Aurstria, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Djibouti, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
Worldwide Distribution - USA (nationwide) including the states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and Puerto Rico and the countries of: Australia, Austria, Bermuda, Canada, Czech Republic, Finland, France, Germany, Ireland, Israel, Italy, Mexico, New Zealand, Norway, Spain and the United Kingdom.
Nationwide Distribution including Puerto Rico and the states of MO, NE, CO, MT, NJ, FL, WA, TX, GA, NY, KS, NH, VA, HI, PA, MI, IA, CA, NC, AZ, UT, LA, IL, TN, ME, MN, KY, CT, OR, NV, AL and NM.
Nationwide Distribution including the states of AK, AL, AR, AZ, CA, CO, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.
Nationwide Distribution including Arizona, California, Colorado, Georgia, Florida, Illinois, Iowa, Kentucky, Louisiana, Maryland, Massachussets, Michigan, Minnesota, Missouri, New Jersey, New Mexico, New York, North Carolina, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington DC, Washington, West Virginia, and Wisconsin.
Nationwide Distribution including Puerto Rico and all States in continental USA except ID, MT, and NH.
Nationwide Distribution including Puerto Rico
Worldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Canada and Guam.
Product was distributed to the following states: ID, OR & WA.
USA Nationwide Distribution - including the states of: CO, IL, IN, MA, SC and WI.
Products are distributed to one sole consignee in Washington and sold directly to walk-in consumers from the production site.
Nationwide Distribution including the states of AZ, CO, DE, FL, ID, LMA, MI, NH, NJ, NM, PA, RI, TX, and VA.
Worldwide Distribution - USA including Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV. and the countries of Australia, Dominican Republic, Uruguay, Ecuador, Chile, Taiwan, Pakistan, Colombia, Argentina, Korea Republic, New Zealand, Guatemala, Thailand, Peru, Bahamas, Philippines, Trinidad and Tobago, Japan, Ireland, India, Singapore, China, Canada and Mexico.
Nationwide distribution: Arizona, California, Florida, Idaho, Nevada, New Mexico, North Carolina, Oregon, Puerto Rico, South Carolina, Texas, Virginia, and Washington.
Florida, Idaho, California and Hong Kong. This product can be ordered on line.
Worldwide Distribution-USA (nationwide) and the countries of Austria, Belgium, Czech Republic, Belgium, Denmark, Spain, Great Britain, Hungary, Ireland, Italy, Netherlands, Poland, Morocco, Netherlands, Poland, Portugal, Saudia Arabia, Sweden, Turkey, and South Africa.
Worldwide Distribution-USA (nationwide) and the countries of Canada, EU, and Asia.
Distributed in New York, Virginia, Illinois, Maryland, and exported to Barbados.

Product Description
Platelets Pheresis Leukocytes Reduced Irradiated
Blood and Blood Products for Reprocessing
Platelets pooled Leukocytes Reduced Irradiated
Fougera Ketoconazole Cream 2%, 15g tube, Rx only, Labeled with E. Fougera & Co., a division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0099-15
Red Blood Cells (Apheresis) Leukocytes Reduced
Dual Tip Marker, Sterile Product Usage: A writing instrument intended to mark paper and plastic items around the sterile field during surgery. It has two tips. One is black for miscellaneous use. The other is for surgical skin marking.
GREEN DAY DRIED COCONUT, Net Wt: 3oz (85g), UPC bar code 6 950296 800744 -- Manufacturer: Jiangmen Xinhui Parksun Food Co., Ltd. -- Add: Donggua Hill, Beitou Village, Qibao, Xinhui District, Jiangmen City, Guangdong, Produce of P.R.C. -- Packed For: Domega NY International Co., Ltd., 1916 West 13th Street Brooklyn, N.Y. 11223 Tel: (646) 388-3032, Fax: (718) 499-2603 -- Nutrition Facts: Serving Size 100g -- Servings Per Container 0.9 --- The product is packed in a sealed, flexible plastic bag.
CLONAZEPAM ORALLY DISINTERGRATING Tablets, USP, 0.5 mg, 60 tablets (10 blister cards of 6 tablets each), TEVA PHARMACEUTICALS USA, Sellersville PA 18960, NDC #0555-0096-96
Access Immunoassay System; P/N 107405S Product Usage: The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
Access 2 Immunoassay System; P/N 107405S 2/12 The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
Synchron LXi 725 Clinical System; P/N 107405S Product Usage: The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
UniCel DxC 600i Synchron Access Clinical System; P/N 107405S Product Usage: The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
TEV-TROPIN (somatropin (rDNA origin) for injection) 5 mg (15 IU). Prescription Only. Distributed By: TEVA Biologics & Specialty Products Division of Teva Pharmaceuticals USA, Sellersville, PA 18960 Manufactured in Israel.
Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 The IM2 Data Management System consists of the IM2 Data Manager Software, Desktop Computer, keyboard, mouse, and a unidirectional serial cable. The IM2 software is used to store, retrieve, and process laboratory data received via a unidirectional serial connection from the ABX Micros 60.
Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
Amoxicillin for Oral Suspension, 125mg/5mL, a) 80 mL (NDC 43598-222-80); b) 100mL, (NDC 43598-222-52); c)150 mL (NDC 43598-222-53) bottles, Rx only, Dist. By: Dr. REDDY'S Laboratories, Inc., Bridgewater, NJ 08807
Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a human patient.
Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir, Catalog number 05232732001. Used with the cobas CT/NG 4800 System, for in vitro diagnostics.
Siemens Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridge (DF61) The Phosphorus (PHOS) method used on the Dimension(R) clinical chemistry system is an in vitro diagnostic test intended for the quantitative measurement of phosphorus in human serum, plasma, and urine.
0.9% Sodium Chloride Injection, USP, 50 mL, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7984-36 Hospira, Inc., Lake Forest, IL 60045
BD Vacutainer C&S Transfer Straw Kit C&S Preservative Plus Urine Tube. 4.0 ml, 13 X 75 mm STERILE REF 364953. Becton Dickinson & Company, Franklin Lakes, NJ USA, The kit consists of a transfer straw and urinalysis tube intended for UA chemistry urine testing.
Medtronic Prostiva RF Therapy Generator. The Prostiva RF system is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cm3.
LEEP REDIKIT Product No. 6060 In a Loop Electrosurgical Excision Procedure, a thin, low-voltage electrified wire loop is used to cut out abnormal cervical tissue. The cartridges of Polocaine and Xylocaine with Epinephrine contained in the LEEP RediKit are local anaesthetic which the physician may choose from during the procedure.
Brunswick and Bumble Bee Brand 5oz Chunk Light Tuna in Water.
Bumble Bee Brand 5oz Chunk Light Tuna in Vegetable Oil
Bumble Bee Brand 5oz Chunk White Albacore in Water
Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. For the rapid, qualitative detection of human hemoglobin in feces.
Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOBSTR. For the rapid, qualitative detection of human hemoglobin in feces.
Kroger Value Wheat Bread, PAN DE TRIGO, net wt/peso neto 22.5 oz (1 lb 6.5 oz) 637g UNBLEACHED ENRICHED FLOUR***CONTAINS: WHEAT AND SOY.*** DISTRIBUTED BY/DISTRIBUIDO OR THE KROGER CO., CINCINNATI, OHIO 45202.
Tender Twist Wheat Bread NET WT 20 OZ (1 LB 4 OZ) 566G and 22.5 oz (1 LB 6.5 OZ) 637 g plastic bags ***INGREDIENTS: UNBLEACHED ENRICHED FLOUR***CONTAINS: WHEAT, SOY. DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202'' Sold under the following brands: QFC Quality Food Centers & Fred Meyer
Tender Twist 100% Whole Wheat Bread 24 oz (1 LB 8 OZ) 680g***INGREDIENTS: UNBLEACHED ENRICHED FLOUR***CONTAINS: WHEAT, SOY. DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202'' Sold under the following brand names: Fred Meyer & Goodyman
Fred Meyer Tender Twist Honey Cracked Wheat Bread 24 oz (1 LB 8 OZ) 680g***INGREDIENTS: UNBLEACHED ENRICHED FLOUR***CONTAINS: WHEAT, SOY. DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202''
Smiths Medical, BCI Remote Alarm Cable (Normally Open & Normally Closed), Reorder Numbers: WW3398NO & WW3398NC. For use with respiration carbon dioxide measurement equipment. Product Usage: The BCI Remote Alarm Cable is designed for use with the 9004 Capnocheck Capnography (Plus or Sleep) system to transfer alarm signals from the Capnocheck Capnography system to a remote alarm system. The BCI Remote Alarm Cable and the 9004 Capnocheck Capnography systems are intended for use in all critical environments including ventilatory applications, patient transport, and anesthesia.
Chicken of the Sea Brand 5-ounce chunk whitealbacore tuna in water. UPC: 4800003355, Case UPC 4800003355: 24 cans per case, Shipper display UPC 4800016335: 80 cans per case, Pallet display UPC 4800023355: 1008 cans per pallet Product labeling reads in part:''***Chicken of the Sea CHUNK WHITE ALBACORE TUNA IN WATER***NET WT. 5 OZ (142g)***Send product comments to***Chicken of the Sea Intl.,***P.O. Box 85568, San Diego, CA 92186-5568***''.
Chicken of the Sea 5-Ounce Chunk Light Tuna in Oil.Sold in single cans. 24 cans per case. UPC 48000 00195 Product labeling reads in part:''***Chicken of the Sea CHUNK LIGHT TUNA IN OIL***NET WT. 5 OZ (142g)***Send product comments to***Chicken of the Sea Intl.,***P.O. Box 85568, San Diego, CA 92186-5568***''.
CHU MINH TOFU Fresh Soybean Cake (Tofu), net weight 16 oz. The UPC is 8 18140 00002 2. The product is labeled in parts: ''***CHUMINH TOFU***Fresh Soybean Cake (Tofu)***Ingredients: Soybean, Water, Calcium Sulfate***NET WT. 16 OZ***Perishable***Keep Refrigerated***CHUMINH TOFU INCORPORATION***6754 Martin Luther King Way S. Seattle, WA 98118***(206) 723-4273***''.
CHU MINH TOFU Fried Soybean Cake (Tofu), net weight 12 oz. The UPC is 8 18140 00003 9. The product is labeled in parts: ''***CHUMINH TOFU***Fried Soybean Cake (Tofu)***Ingredients: Soybean, Water, Calcium Sulfate, Corn Oil***NET WT. 12 OZ***Perishable***Keep Refrigerated***CHUMINH TOFU INCORPORATION***6754 Martin Luther King Way S. Seattle, WA 98118***(206) 723-4273***''.
Siemens Dimension(R) EXL(TM) LM (Siemens Material Number 10486890). Intended to measure a variety of analytes in human body fluids.
Siemens Dimension(R) EXL(TM) LM STM (Siemens Material Number 106393377). Intended to measure a variety of analytes in human body fluids.
Siemens Dimension(R) EXL(TM) 200 (Siemens Material Number 10636929). Intended to measure a variety of analytes in human body fluids.
Arrow/Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berman Angiographic Balloon Catheter. The Arrow Berman(TM) Angiographic Catheter is indicated for use in right heart catheterization for cardiac angiography, and measurement of the right heart and pulmonary artery pressures. It can be sued to inject radiopaque media and measure pressures in any chamber or vessel that can be entered from the right heart. The Arrow Berman(TM) Angiographic Catheter is also indicated for use in Balloon Occlusion Femoral Angiography (BOFA) of the ipsilateral leg for adult patients. The Arrow Reverse Berman(TM) Angiographic Catheter is indicated for balloon occlusion pulmonary angiography.
Mrs. Bridges Scottish Raspberry Preserve (''Jam''); Net Wt. 42g /1.5oz; service size 15g; servings per package: 2.8; ID 3779300377 Manufactured for: Kimm & Miller (UK) Ltd. mille Road, Bedford, MK429TW. United Kingdom; Manufacturer: Mackays Ltd., James Chalmers Road, Kirkton Ind Estate, Arbroath, Scotland UK DD113LR.
Aniracetam & Choline capsules, 430mg Aniracetam 88mg Choline, a) 30 count bottle b) 60 count bottle, c) 90 count, d) 180 count , OTC, BoostYourGrade, LLC Orlando, FL 32826
NOOTROPA COGNITIVE ENHANCEMENT SUPPLEMENT, 400 mg Aniracetam Capsules 60 count bottle, OTC Manufactured & Packaged in the USA for NOOTROPA.COM. DEVELOPED BY: Digital Superfuture Limited Arntel Building 9B 148 Des Voeux Rd. Hong Kong.
Aniracetam and Choline, Aniracetam 460 mg, Choline 76 mg, 180 capsules per bottler, non-Rx, distributed by BoostYourGrade, BoostYourGrade, LLC Orlando, FL
Piracetam & Choline, 390mg Piracetam 104mg Choline Capsules, a) 30 count bottle, b) 100 count bottle, OTC, BoostYourGrade, LLC, Orlando, FL. 32826 ,
Brain Defogger, Piracetam 390mg Choline 104mg capsules, 100 count bottle, OTC, BoostYourGrade, LLC, Orlando, FL. .
BoostYourGrade.com, Piracetam 390mg Choline 104mg capsules, 250 count bottle, OYC, BoostYourGrade, LLC, Orlando, FL 32826
Oxiracetam & Choline , Oxiracetam 460mg Choline 110mg capsules a) 30 count bottle, b) 60 count bottle, c) 90 count bottle, OTC, BoostYourGrade, LLC, Orlando, FL. 32826
Propolis Chunks-Coarse Ground, Standardized Bee Propolis Lot #: SDM-10081155/60, EXP: 10/14, 1# BAG.
Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cortical stimulation mapping procedures.
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE AG TH, Part No. 5863506, Current R630; Product Usage: The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE TH, Part No. 7339125, - Current R630; Product Usage: The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE Impression TH, Part No. 7341410, Current R630; Product Usage: The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE TH 2.0, Part No. 8139839, Current R630; Product Usage: The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE TH 2.1, Part No. 8147667, Current R640; Product Usage: The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE TH 2.2, Part No. 10568431, Current R640; Product Usage: The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: Primeview 3i, Part No. 7341428, Current R610/R630; Product Usage: The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: Primeview 3i 2.1, Part No. 8147675, Current R640; Product Usage: The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: Primeview 3i 2.0, Part No. 8139847, Current R630; Product Usage: The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.
STERRAD 200 Sterilization System, P/N 10201 Product Usage: The STERRAD 200 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 200 process to inactivate microorganisms on a board range of medical devices and surgical instruments.
Sweet P's Bake Shop branded Caramel Apple Danish Coffee Cake, 14 oz, in a plastic clamshell package, UPC Code: 011225113833
LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures.
Glow 'N Tell 20 cm Tape: 1100-00 (100 strips); 1100-50 (50 strips); 1100-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures.
Happy Kids Creamy Peanut Butter, packed in 8 oz, 12 oz, 28 oz, 40 oz jars; packed 12 jars/box and 6 jars/box (40 oz), and labeled in part ******Manufactured by Producers Peanut Co., Inc. 337 Moore Ave., Suffolk, VA 23434***
Happy Kids Crunchy Peanut butter, packed in 8 oz, 12 oz, 28 oz, packed 12 jars/cs and 40 oz jars, packed 6 jars/cs; jars are labeled in part ***Manufactured by Producers Peanut Co., Inc. 337 Moore Ave., Suffolk, VA 23434***
Bulk Creamy/Smooth Peanut butter, packed in plastic 4 lb tub, packed 6 tubs/box; 5 lb tub, packed 6 tubs/box, and 35 lb buckets under private labels: Peanut Kids, Eden and American Farm Peanut Butters, and labeled in part ***Manufactured by Producers Peanut Co., Inc. 337 Moore Ave., Suffolk, VA 23434***
America Farm Peanut Granules, bulk packed in 30 lb plastic bags in a box, and labeled in part ***Manufactured by Producers Peanut Co., Inc. 337 Moore Ave., Suffolk, VA 23434***
Tizanidine Tablets USP, 4 mg, 150-count tablets per bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachepally - 500 090 India; NDC 55111-180-15.
Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count tablets per bottle, Rx only, Mfd. for: Versapharm Incorporated, Marietta, GA; Mfd. by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724; NDC 61748-011-01.

Code Info
Catalog #3694991 appears as Catalog #364953 (Lot #1335484)
all Model 8930 radio frequency (RF) generators are affected
Kit Lot # P205877 - Kit Expiration Date 2/28/2013 - Test Strip Lot # 18004M; Kit Lot # P210125 - Kit Expiration Date 3/31/2013 - Test Strip Lot # 19006M; Kit Lot # P210204 - Kit Expiration Date 3/31/2013 - Test Strip Lot # 19006M; Kit Lot # P212420 - Kit Expiration Date 4/30/2013 - Test Strip Lot # 1X009M; Kit Lot # P212421 - Kit Expiration Date 4/30/2013 - Test Strip Lot # 1X009M; Kit Lot # P210194 - Kit Expiration Date 4/30/2013 - Test Strip Lot # 1X010M; Kit Lot # P217043 - Kit Expiration Date 5/31/2013 - Test Strip Lot # 1Y012M; Kit Lot # P234499 - Kit Expiration Date 11/30/2013 - Test Strip Lot # 25011M; Kit Lot # P234664 - Kit Expiration Date 11/30/2013 - Test Strip Lot # 26012M; Kit Lot # P238025 - Kit Expiration Date 12/31/2013 - Test Strip Lot # 26012M; Kit Lot # P238028 - Kit Expiration Date 12/31/2013 - Test Strip Lot # 26013M; Kit Lot # P243938 - Kit Expiration Date 12/31/2013 - Test Strip Lot # 26012M.
Kit Lot # P207830 - Kit Expiration Date 2/28/2013 - Test Strip Lot # 18005M; Kit Lot # P210191 - Kit Expiration Date 4/30/2013 - Test Strip Lot # 1X009M Kit Lot # P210192 - Kit Expiration Date 4/30/2013 - Test Strip Lot # 1X010M; Kit Lot # P217033 - Kit Expiration Date 5/31/2013 - Test Strip Lot # 1Y011M; Kit Lot # P217034 - Kit Expiration Date 5/31/2013 - Test Strip Lot # 1Y012M; Kit Lot # P217035 - Kit Expiration Date 6/30/2013 - Test Strip Lot # 1Z013M; Kit Lot # P222808 - Kit Expiration Date 6/30/2013 - Test Strip Lot # 1Z013M.
3018CA2CKP, 3018CA3CKP, 3018CA4CKP, 3018CAACKP, 3018CABCKP, 3018CACCKP, 3018CAECKP, 3018CB3CKP, 3018CADCKP BEST BY DATE: 01/18/17.
3015CB1CLH3015CB2CLH 3015CB3CLH 3015CB4CLH 3015CBACLH 3015CBBCLH 3015CBCCLH 3015CBDCLH 3015CBECLH BEST BY DATE 01/15/17 and 01/18/17

Product Quantity
71 cases total ( 50 x 85 gm packages per case)
557 30 count botles, 672 60 count bottles, 1,102 90 count bottles, 250 180 count bottles
511 30 count bottles, 4103 100 count bottles
472 - 30 count bottles; 203 - 60 count bottles; 458 - 90 count bottles
1,134 cases (13,608 individual coffee cakes)
1101- 4 lb tubs; 573- 5 lb tubs; 181- 35 lb buckets; Total 49,949 lb

Reason for Recall
Blood product, which may have been exposed to unacceptable temperatures during storage, was distributed.
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
Blood products, collected from a donor who received a piercing within 12 months of donation, were distributed.
Blood products, collected from a donor who received a piercing within 12 months of donation, were distributed
Blood products, which did not meet acceptable product specifications, were distributed.
Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Blood product, which may have been unacceptable, was distributed.
Blood products, collected from donors whose donor suitability was not adequately determined, were distributed.
Blood products, collected from a donor who had previously tested reactive for hepatitis, were distributed.
Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.
Blood products, collected from a donor possibly at increased risk for Creutzfeldt-Jakob Disease (CJD), were distributed.
Blood product, collected from a donor who reported post donation illness, was distributed.
Blood products, collected from a donor who reported a post donation illness, were distributed.
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
Blood products, collected from a donor who was previously deferred, were distributed.
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed
Blood product, labeled as an AS product but with no red cell preservative solution added, was distributed.
Failed Impurities/Degradation Specifications: Ketoconazole Cream 2% is the subject of a voluntary drug recall by Fougera due to an Out Of Specification result for an unknown degradant product
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed.
Blood Products, collected from a donor who received varicella zoster vaccine less than 28 days before donating, were distributed.
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
Blood products, collected from a paid donor but incorrectly labeled with the ''volunteer donor'' classification, were distributed.
Blood products, collected from a donor who received a tattoo within one year of donation, were distributed.
Blood products, collected from a donor who had taken aspirin, were distributed.
Blood products, which were incorrectly labeled as negative anti-K, were distributed.
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Dual Tip Marker has inconsistent ink flow on the black permanent ink side.
The products contained undeclared sulfites (251 ppm and 398 ppm respectively) based on sampling and analysis by New York State Department of Agriculture & Markets.
Failed Content Uniformity Specifications: Recall is being carried out due to an out-of-specification result for content uniformity.
Beckman Coulter is initiating a recall due to a defective newly released aluminum incubator belt pulley that may rub against the light shield, which causes the formation of debris. Debris that is caused by the incubator belt pulley rubbing against the light shield can fall into the reaction vessels (RVs) and present a risk of erroneous test results.
Labeling: Label Mix-up: Units of Lot 201131320087 are packaged in cartons labelled for Needle-Free Head B, but contaiin Needle-Free Head A
Animas has identified a component issue affecting a small supply of the Animas(R) 2020 insulin pumps. The component issue may trigger the pumps to sound a false alarm or warning related to one of the following: - Loss of prime; -Occlusion; or -No cartridge detected.
Horiba Medical is recalling ABX Micros IM2 Data Management System because it may display incorrect patient test results under unanticipated operating conditions.
Issues have been detected in the Ingenuity TF PET/CT currently running software version 4.0.60605.0 that if they were to re-occur, could cause a risk for patients, users or service personnel, including inaccurate standard uptake values (SUV). Philips Medical Systems (Cleveland), Inc. is issuing a software update to address the issues.
Microbial Contamination of Non-Sterile Products: Suspensions made from these lots of Amoxicillin 125 mg/5 mL showed yeast and mold growth at the 14 day time point.
Update Instruction For Use for Preventative Maintenance (PM) Schedule and addition of Odometer software to monitor accumulative fluid volume infused by the pump
Certain lots of Reagent reservoirs, 50mL used on the cobas 4800 System, may not have a separation in the lower part of the reservoir. As a consequence, pipetting errors can occur due to uneven distribution of reagent. These pipetting errors may lead to delayed results and wasted reagent.
Siemens Healthcare Diagnostics has initiated a voluntary field action for Dimension(R) PHOS Flex(R) Reagent due to reagent interaction causing falsely depressed Creatinine results when EZCR is processed from open wells that are in close proximity to open wells of PHOS reagent.
Lack of Assurance of Sterility: The product is being recall due to the product lot being incorrectly released without meeting product specifications. There is the potential for the solution to leak from the administrative port to the fill tube seal.
Biotest reagent A1 red blood cell, with higher than expected cell concentration, was distributed.
The BD Vacutainer Urinalysis Transfer Straw Kit #364991, Lot 1335484 has preprinted polybags which are incorrectly labeled as Catalog #364953. BD advises any Customer who purchased this Kit that the Tube in this Kit is not a C&S tube. If a Customer relies solely on the polybag labeling and uses the Tube inside the Kit for the purpose of collecting urine for culture and sensitivity, it is possible they would obtain an erroneous result since the Urinalysis Tube contained in the Kit does not contain any preservatives.
Medtronic has found through device testing that if the optional footswitch is not connected to the Model 8930 RF generator during use, an electrostatic discharge (i.e. static electricity) to the footswitch connector port may toggle the RF output on or off. If this were to occur, it could result in unintentionally starting or stopping the lesion process, depending on the current status of the equipment. The status messages on the display screen and associated audible alarms operate as intended, and would notify the clinician of any change in status.
LEEP RediKit Products (for use in Loop Electrosurgical Excision Procedures) have Xylocaine (Lidocaine) HCL (2%) listed on the tray lid label but this is not included in the contents of the kit, which contained Polocaine (Mepivacaine) HCL (3%) instead (which was not listed on the tray label).
Bumble Bee Foods, LLC, has issued a voluntary recall on specific codes of 5-ounce Chunk White Albacore and Chunk Light Tuna products. The recall has been issued because the products do not meet the companys standards for seal tightness.
The test strips in the affected product lots of the OC Light immunological fecal occult blood test are being recalled because they may not be stable through their labeled shelf-life. There may be a possibility of obtaining false negative results when using the affected lots.
The firm was notified of bread with traces of visible ink was discovered which later led to the discovery of plastic pen pieces.
In rare instances, the BCI Remote Alarm Cables (BCI Cable) are not transferring alarms when used with some remote nurse alarm systems.
Tri-Union Seafoods LLC is voluntarily recalling a limitedamount of Chicken of the Sea brand 5-ounce cans of chunk white albacore tuna in water and Chicken of the Sea brand 5-ounce cans chunk light tuna in oil, because the seams on the lids of the cans do not meet the standard for seam quality.
All fresh tofu and fried tofu products are recalled because they were made in a facility with no available hot water.
Possibility that the inner pouch may be compromised. The product is packaged in two pouches - a sterile inner pouch within an external pouch. NexPosure Retractors contained in a breached inner pouch have an increased risk of contamination (i.e.; loss of product sterility) if proper aseptic technique is not followed when transferring the inner package into the sterile field. Patient infection may occur due to loss of product sterility.
Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an increase in System Check failures due to high System Check LOCI results. Upon further investigation, Siemens has determined that many of these errors are due to the current limit set for System Check LOCI results. The errors have no impact on results, but they may cause customer inconvenience. Siemens has validated a new limit for System Check LOCI results that can be used with Software Version 10.0 in order to resolve the issue.
The product specifications sheet, part of the Instructions for Use (IFU), for the specified product numbers, reference Renografin-76 contrast medium (viscosity of 8.4 centipoise), which is no longer available. Firm is in the process of updating the labeling for these products. In the meantime, when choosing an alternative contrast medium, health care providers are instructed to select a contrast medium with a viscosity of 8.4 centipoise or lower for use with the pressure and flow settings specified in the current IFU.
The firm is initiating the recall for Scottish Raspberry Preserve due to discovery of contaminants.
Marketed Without an Approved NDA/ANDA: The products are unapproved drugs
Beehive Botanical, Inc is recalling several lots of Propolis 55-60% due to positive identification of Fluvalinate.
If the headphone jack is in use during a surgical procedure with the OCS2 and a non-intended voltage (such as static electricity) comes in contact with the outer case of the unit, that voltage could be transmitted to the patient and could be a potential source of injury.
Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance defects and several safety issues that were not considered critical (for immediate correction) for the safe use of the device.
The recall was initiated because Advanced Sterilization Products (ASP) has determined that the STERRAD 100NX and STERRAD 200 Sterilization Systems may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions.
Sweet P's Bake Shop branded Caramel Apple Danish Coffee Cake contains undeclared walnuts.
Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised.
Peanut butter may contain aflatoxins above allowable levels.
Labeling Illegible: There is a possibility that the bottle labels do not contain the strength of the product as well as other printing details.
Subpotent Drug: Out Of Specification results for assay at the stability time-point of 24 months.