Recalling Firm
American National Red Cross, Penn-Jersey Region
Community Blood Centers of Florida, Inc.
Community Blood Centers of South Florida, Inc.
Dept Of Veterans Affairs Office Of Information & Technology
American Red Cross Blood Services Tennessee Valley Region
Indiana Lions Eye and Tissue Transplant Bank

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

Distribution Pattern
The recalling firm notified the consignees located in Washington and California by letter dated 11/28/2008. The consignees responded the units have been transfused.
Nationwide Distribution-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, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY.
Nationwide and Puerto Rico and internationally to Barbados, Brazil, Canada, Cyprus, Equador, France, Germany, Israel, Mexico, and Netherlands.
Nationwide Distribution, including the states of TX, CA, NJ, NY, SD, RI, WV, IL PA, NC and MN.
Nationwide, Puerto Rico, Bermuda and Panama
Worldwide Distribution-USA (nationwide) and the countries of Denmark, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Spain, Sweden, UK, Poland, France, Australia, Chile, Canada, India, Japan, New Zealand, Peru, South Africa, Colombia, Ukraine, and UAE.
Nationwide Distribution including WI, MO, MA, CT, AL, IL, WA, CA, RI, MD, NJ, NC and TX.
Nationwide Distribution including CA, FL, IL, MA, MD, MN, NM, NY, OH, OK, and TX.
Nationwide; China, Costa Rica, Germany, Ireland, Mexico, Singapore, and Taiwan.
Distributed in the state of Massachusetts
Software was distributed to blood banks nationwide.
The product was distributed to one wholesaler - Associated Food Stores (AFS) Farr West, Far West, Utah. The January 31, 2015 code was first not thought to have been distributed to retail, however; Associated Food Stores corrected this information and issued a second recall notice because the product had been distributed from their warehouse to retail. Lot codes with Best Buy: DEC 15 2014 and DEC 15 2014 were not distributed out of Acme's warehouse and are currently under their control.
Worldwide Distribution - USA including California and Internationally to Spain and Korea
Nationwide, and France Johnson and Johnson Affiliate
Product was distributed in Idaho and Oregon
Distributed in the states of TN, FL, VA, WA and NV.
US Nationwide Distribution including the states of CA & MT.
Worldwide Distribution-USA including the states of New York, Michigan, Colorado, Texas, Iowa, Florida, Georgia, Ohio, Wisconsin, Oregon, Alabama, Illinois, Utah, Oklahoma, West Virginia and California and the countries of Canada, European Union, South Africa, Korea and Brazil.
Worldwide Distribution-USA including the states of CA, FL, GA, MI, MN, NJ, NY, OH, OR, RI, TX, VA, and WA, and the countries of Germany, Spain, and UK.
USA Nationwide Distribution including the states GA, OH, GA, NC and ME.
Nationwide Distribution including the states of AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA & WI.
US Nationwide Distribution including the states of FL, CA, WA, AZ, NC, KY, DE, AZ and MO.
US Nationwide Distribution including the states of California, Florida, Texas, Illinois, Indiana, Maryland, Pennsylvania and Canada.
US Nationwide Distribution including the states of Arizona, California, Idaho, Illinois, North Carolina, Ohio, Utah, Washington and US Virgin Islands
Worldwide Distribution - USA and the country of Canada.
Pennsylvania, Ohio, North Carolina, Georgia and Illinois, New Jersey and New York.
NY, Philadelphia, PA and metro Boston, MA areas.

Product Description
Yangchun Noodles, 10 case, 12 bgs per case
Blood and Blood Products for Reprocessing
Platelets Pheresis Leukocytes Reduced Irradiated
Leukine sargramostim 5 x 500 mcg/mL vial, liquid injection, Sterile Rx only, Mfd by: Bayer HealthCare Pharmaceuticals, LLC Seattle, WA 98101 U.S. Lic. No. 1791 NDC 58468-0181-2
Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion - 2.5mm Drill Bit, graduated 12mm - 26mm adjustable depth, Part Number 03.613.011. Synthes Vectra System, Synthes Vectra-One System and Synthes Vectra-T System is intended for anterior plate and screw fixation of the cervical spine (C2-C7).
Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion, Adjustable Drill Stop, Part Number 03.613.012. Synthes Vectra System, Synthes Vectra-One System and Synthes Vectra-T System is intended for anterior plate and screw fixation of the cervical spine (C2-C7).
SLIM XTREME Herbal Slimming Capsule, supplied in 30-count bottles. Another Product Forumulated and Distributed By: Globe All Wellness, LLC Hollywood, FL 33020 www.diet66.com Inquires Call 877.842.9873
Siya Pan Gilori Net Wt. 180g. Distributed by: Miami Growers Inc. 80 Broadway Jersey City, NJ 07306 T 201-985-9322, 201-369-1500 Visit us: www.miamigrowersinc.com UPC 0893056003800
THERA PEARL 3-in-1 BREAST THERAPY, 2 hot and cold packs in plastic box. The Thera Pearl 3-in-1 Breast Therapy is a reusable therapeutic hot and cold pack for use with pain, swelling, engorgement, plugged ducts or mastitis associated with breast feeding or to help encourage let-down while using a breast pump.
Yoghund Organic Banana & Peanut Butter, Organic Frozen Yogurt for Dogs, 4-3.5 fl. oz. cups (4 pack), 14 fl. oz., (416 ml).
ESTEE LAUDER DayWear Sheer Tint Release, Advanced Multi-Protection Anti-Oxidant Moisturizer Broad Spectrum SPF15, All Skin types, 1.7 FL. OZ. LIQ/50 ml (tube inside a unit carton) with UPC No. 2713179904, Code WKEM-01, and 1.5 mL foil sample packets, ESTEE LAUDER, DIST., NEW YORK, N.Y. 10022 NDC 11559-008-01
Trilogy F/M Acetabular Shell without holes. Several ODs: 40MM, 42MM, 44MM, 46MM, 48MM, 50MM, 52MM, 54MM, 56MM, 58MM, 60MM, 62MM, 64MM, 66MM, 68MM, 70MM. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
Trilogy F/M Acetabular Shell without holes SOLID HA. Several ODs: 38MM, 40MM, 42MM, 44MM, 46MM, 48MM, 50MM, 52MM, 54MM, 56MM, 58MM, 60MM, 62MM, 64MM, 66MM, 68MM, 70MM. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
Trilogy F/M Acetabular Shell with Uni-Hole. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
Trilogy Acetabular Shell Spiked. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
Trilogy Acetabular Shell with Cluster Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
Trilogy Acetabular AB Shells with Cluster Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
Trilogy Acetabular Shells with Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
Trilogy Acetabular AB Shells with Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
Carboplatin Injection, 600 mg/60 mL (10 mg/mL), 60 mL, Cytotoxic Agent, Sterile, Multi-Dose Vial, Rx only, For IV Use, Hospira, Inc., Lake Forest, IL 60045, Product of Australia, NDC 61703-339-56.
Carboplatin Injection, 450 mg/45 mL (10 mg/mL), 45 mL, Cytotoxic Agent, Sterile, Multi-Dose Vial, Rx only, For IV Use, NDC 61703-339-50 (Hospira label) and NDC 61703-360-50 (Novaplus label), Hospira, Inc., Lake Forest, IL 60045, Product of Australia.
Oxoid Antimicrobial Susceptibility Test Discs, Aztreonam 30 ug, IVD, REF CT0264B, Oxoid Ltd., UK, oxoid@thrmofisher.com (Both Remel & Oxoid, Ltd are a part of Thermo Fisher Scientific) An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure, by a disc-agar diffusion technique or a disc-broth elution technique, the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents (Aztreonam).
PREMIER LIFECARE RECLINER 5400 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012. A multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion.
PREMIER CARE RECLINER 5570/5574 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012. A multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion.
Cozy Comfort Premier Recliner 5580 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012. A multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion.
Designer Care Cliner 6700/6704/6710 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012. A multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion.
Red Blood Cells (Apheresis) Leukocytes Reduced
Platelets Pooled Leukocytes Reduced Irradiated
VistA Blood Establishment Computer Software (VBECS)
Capture-P Indicator Red Cells, 1 x 11.5mL
Isovue -370 (Iopamidol) Injection 76%, Prefilled 10 x 75 mL (NDC 0270-1316-66), 10 x 100 mL (NDC 0270-1316-67), 10 x 125 mL (NDC 0270-1316-68) Power Injector Syringe, Rx Only, Manufactured for Bracco Diagnostics Inc., Princeton, NJ 08543 by Nycomed GmbH 78224 Singen (Germany).
Isovue -300 (Iopamidol) Injection 61% Prefilled, 10 x 100 mL Power Injector Syringe, Rx Only, Manufactured for Bracco Diagnostics Inc., Princeton, NJ 08543 by Nycomed GmbH 78224 Singen (Germany); NDC 0270-1315-67.
Anspach Effort, Inc., 98-0061 MA-15C Bearing Sleeve with Removable Bur Guard. A reusable device used with dissection tools; designed for Transphenoidal and Skull base procedures.
Blood Bank Control System (BBCS) Primary Application 5.0 - software for device.
Blood Bank Computer Systems (BBCS) Primary Application 5.0 - device software
Canned mandarin oranges labeled in part: ''WESTERN FAMILY Choice Selections Mandarin Oranges Naturally Sweet in Mandarin Orange Juice NET WT 10.5OZ (297g)***Ingredients: Mandarin Oranges, Mandarin Orange Juice. Proudly Distributed by Western Family P.O. Box 4057, Portland, OR 97208 U.S.A.***Product of China***0 15400 01241 6***''
ConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm Orthopedic manual surgical instrument - Bone Punch
Ortho Pipetter Volume Verification Kit Ortho Clinical Diagnostics a Johnson & Johnson Company 1001 US Highway 202, Raritan, NJ 08869 USA 1-800-421-3311 Product Code 937924
Blood Grouping Reagent, Anti-e (Human Monoclonal)(IgM)(For Further Manufacturing Use) EMD Millipore Catalog Number: WD-1L-BK
Labeled in part: ***Meningococcal***Groups A, C, Y and W-135***Oligosaccharide***Diphtheria***CRM***197***Conjugate***Vaccine***Menveo(R)***Powder and solvent for injection***NDC 46028-208-01***Rx Only***NOVARTIS***vaccines***Store refrigerated, away from the freezer compartment, at 36 degrees F to 46 degrees F (2 degrees C to 8 degrees C), protect from light***for intramuscular injection, read the package leaflet before use***
WSI Pride Plus Amprolium Crumble 1.25%, packaged in a 50 lb. bag. The Product code/number is 104636. Tag is tan in color; with the lot number and product number located at the bottom of the tag just above the tag sew line. The product is labeled in parts: ''***WSI Pride Plus Amprolium Crumble 1.25%***For Beef and Dairy Calves***MEDICATED An aid in the prevention and treatment of coccidiosis caused by Eimeria bovis and E. zurnii in calves***ACTIVE DRUG INGREDIENT***Amprolium (Corid) 1.25%***MANUFACTURED BY WESTERN STOCKMEN'S, CALDWELL, ID 83605*** 208-459-0777***''.
Zicam Extreme Congestion Relief (oxymetazoline HCl) nasal gel, 0.05%, 0.50 fl. oz. (15 mL) spray bottle, Developed and distributed by Zicam LLC, Scottsdale, Arizona 85255, a wholly owned subsidiary of Matrixx Initiatives Inc, NDC 62750-005-10, UPC 7 32216 20410 0.
PredniSONE Tablets, USP, 10 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1473-01), b) 1000-count tablets per bottle (NDC 0143-1473-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatowntown, NJ 07724.
Exactech NOVATION CROWN CUP, NEUTRAL LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 130-32-53. Exactech Hip Systems are indicated for use in surgery for hip replacement.
Exactech NOVATION CROWN CUP +5mm LATERALIZED LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 136-32-53. Exactech Hip Systems are indicated for use in surgery for hip replacement.
Solara 3G Custom Manual Wheelchair Product Usage: To provide mobility to a person restricted to a sitting position.
Mama Tere Cebada Natural Barley Flour Net Weight /Peso Neto: 12 oz (340g) Family Food Distributors Bergen Avenue Kearny, NY 07032 UPC 7412003000259
Taztia XT(diltiazem HCI extended release capsules, USP, Once-A-Day Dosage, 360 mg, 90 Capsules per bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, Distributed by: Watson Pharma, NDC 62037-700-90.
Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400. Also branded as Reliability Plus byDrive. The Portable Oxygen Concentrator is intended to deliver concentrated oxygen for adult patients with chronic pulmonary diseases.
SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic procedures.
Custom Breast Biopsy Tray, Catalog # B 9-16261, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.
Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.
P10 Tobii battery box (product number 510410) Product Usage - Battery pack for MyTobii P10 Device. MyTobii P10 is a portable eye-controlled communication device featuring the Tobii Eye Control system.
Carisoprodol Tablets, USP, 350 mg, packaged in a) 500-count tablets per bottle (NDC 0143-1176-05) and b) 1000-count tablets per bottle (NDC 0143-1176-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724.
Diagnostic Hybrids, Inc., RhMK, Model #:49-0600, 49-0600A, 49-0102A, and 49-T075A. Culture media, used in the cultivation and amplification of viruses, such as respiratory viruses, enteroviruses, measles, and poliovirus from patient specimens.
EstroGel (estradiol gel) 0.06%, contained in 50-gr metered pumps, 1.25g/pump depression, for use as physician starter samples; product is labeled in part ***Manufactured for ASCEND Therapeutics Herndon, VA 20170 by DPT Laboratories San Antonio TX 78215***
Syeda (drospirenone and ethinyl estradiol), 3 mg/0.03 mg, 3 x 28 tablet blistercards, combination oral contraceptive tablet, Manufactured by Laboratorios Leon Farma S.A., Spain for Sandoz Inc., Princeton, NJ
Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Universal Fluoroscopic Applications
OPTIGEN Food 30; Manufactured by Hitachi Chemical Diagnostics, Mountain View, CA. Distributed by Theridiag, Cedex, France Allergen testing
KODAK INSIGHT DENTAL FILM in SureSoft Packets, Size 2 Single Packet Film, Model Number IP21S, REF/Catalog Number 8118226 --- COMMON/USUAL NAME: Dental Intraoral Radiographic Film -- 20 cartons of 80 packets. Product Usage: Dental intraoral radiography
Annie's Homegrown Rising Crust Four Cheese Pizza. Mozzarella, Provolone, Parmesan and Romano Cheese. Certified Organic, 23.5 oz package. Product UPC: 0 13562-20001 6; Case UPC 1 00 13562 20001 3 Annie's, Inc. 1610 5th Street Berkeley, CA 94710
Annie's Homegrown Rising Crust Spinach and Mushroom Pizza. Spinach, Portobello and Button mushrooms with a Garlic Parmesan cream sauce.. Certified Organic, 25.0 oz package. Product UPC: 0 13562-20005 4; Case UPC 1 00 13562 20005 1 Annie's, Inc. 1610 5th Street Berkeley, CA 94710
Annie's Homegrown Rising Crust Four Cheese Pizza. Mozzarella, Provolone, Parmesan and Romano Cheese. 22.5 oz package. Product UPC: 0 13562-20007 8; Case UPC 1 00 13561 20007 5. Annie's, Inc. 1610 5th Street Berkeley, CA 94710
Ventavis (iloprost) Inhalation Solution, 10 mcg/1 mL, Sterile, 30 Single Use Ampules per carton, Manufactured for Actelion Pharmaceuticals US, Inc, 5000 Shoreline Court, Ste 200, South San Francisco, CA 94080, NDC: 66215-302-30.
MET-Rx EXTREME THERMO RAGE WATERMELON DIETARY SUPPLEMENT, 8 FL. OZ. (240 mL) , Product Number 50390 (Bulk number 50389), UPC 7 86560 50389 1, Label Revision 00B --- Manufactured in the USA by MET-RX Nutrition, Inc. Boca Raton, FL 33487
PURE PROTEIN PROTEIN SHOT 25g PROTEIN, GRAPE Flavor PROTEIN DRINK 2.9 fl. oz. (86 mL), Product Number 50451, Bulk Number 36753 (Vial), UPC 7 49826 50451 3 (Vial), and Product Number 50452, Bulk Number 36753 (Carton of 6), UPC 7 49826 50452 0 (Carton). --- Carefully Manufactured by Worldwide Sport Nutritional Supplements, Inc. Bayport, NY 11705
Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System. Product Usage - used to broach the intramedullary canal of the femur in order to create space for the femoral stem during a hip replacement surgery.
Sybron Endo Lightspeed: LSX Files, 25MM, Part Numbers: 835-2525; LSX Files, 25MM Assorted Kit, Part Numbers: 835-2455; LSX Files, 30MM, Part Numbers: 835-2031. An engine-driven rotary endodontic instrument used during endodontic procedures for cleaning and shaping the root canal.
Dried Preserved Plum packaged in clear 4.4 lb (1904 g) plastic packages. The product comes in bulk form in a brown corrugated box with 10 x 4.4 lb packages. Net weight of one case is 44 lbs.. Product information is provided on the case with product name ''Dried Preserved Plum'' and Net Weight 44 lbs. (Product was destroyed and photos of product are not available). Distributed by Nuera Trading Company Inc., San Leandro, CA. Manufactured by Zi Jing Yuk Hin Enterprises, Guangdong, China.
Lansoprazole Delayed-release Capsules, USP, 30 mg, 500-count capsules per bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., Made in India, NDC 0378-8030-05.
Methocarbamol 750 mg Tablets, 90-count bottle, Mfg by: West-Ward Pharm. Corp., Eatontown, NJ 07724, Packaged and Distributed by: Stat Rx USA, NDC 42549-521-90.
Vietnamese Cinnamon Extra Fancy, product code 43200, Penzeys Spices, Wauwatosa, WI 53222. to be completed
Imperial Nuts and Snacks Chocolate and Peanut Platter. Packed By: Star Snacks CO., LLC, Jersey City, NJ 07305. Net Wt. 26 oz (737 g) UPC 5351946762.
Outer Cardboard Container - China Products Fresh Dried Cabbage. Plastic Bag: Double Swallow Brand, Net Wt 0.15 Kg (529 OZ), Dehydrated Cole, Jiangmen Native Produce Import & Export Company of Guangdong China.

Code Info
2.5mm Drill Bit, graduated 12mm - 26mm adjustable depth, Part Number 03.613.011 - Lots 5443576, 5522810, 5537042, 5557902
All Lots of SlimXtreme with the following format stamped in black ink on the bottom of the bottle ''MFD: XX.XX.20XX EXP: XX.XX.20XX'', which were manufactured overseas, are being recalled.
UPC 0893056003800 No lot code or expiration date
Case: Lot Code: 26812 or earlier Cups: Best By Dates of 9.24.14 or earlier
lots Z011711AA (Hospira label) and Z011711AB (Novaplus label), Exp. 08/2013
ALL Versions of VistA Blood Establishment Computer Software (VBECS)
PSSWM Item Number 238361 Lot #M10135B Exp 2/18/2013
Lot No. 340209114-090712 The lot number consists of the first 9 digits, i.e., 340209114 and is a unique identifier. The Product code is the unique code assigned in the firm's database for this named finished feed product. The number 090712 is September 7, 2012. The tag was made on Sept. 7. This date does not reflect the actual date of manufacture necessarily, as tags are produced at the time an order is placed. In this case, the order was placed on Sept. 7th and at that time the tags were made.
Catalog number: 85035. Lot number 42K283626, expiration May 31, 2013.
All product with best by dates between 09 Jan 2013 and 14 Sep 2013.
Lot # 430855, Expiration Date 12/21/12; Lot # 430856, Expiration Date 12/29/12

Product Quantity
5211 Cases (24 case -3.5 fl.oz cups/4 pack)
1.7 oz. 241,236 tubes; 1.5 mL sample size 544,548 foil packs
101 cartons: Domestic - 95 cartons; Foreign - 6 cartons
40,668 bottles (shipped and sold in cases of 12)
~580 cartons (10 x 4.4lb packages per carton)

Reason for Recall
Man Fon is recalling Yangchun Noodles because they contain undeclared wheat allergen.
Blood products, which tested positive for viral testing but incorrectly entered as negative, were distributed.
Blood products, which were collected from a donor with a history of multiple high risk behaviors, were distributed.
Blood products, collected using equipment for which quality control was not performed, were distributed.
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
Blood product, which did not meet acceptable product specifications, was distributed.
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Blood products, which may have been exposed to unacceptable temperatures during storage, were distributed.
Blood product, labeling/crossmatch tag incorrect or missing information was distributed.
Blood product, which did not meet the acceptable product specifications, was distributed.
Impurities/Degradation Products: A confirmed out of specification result for Leukine sargramostin lot B18827 occurred at the three month time point.
Although the reported incidence is low, there is the potential for the drill stop to slip on the drill bit resulting in an adverse event.
Marketed Without an Approved NDA/ANDA: Product tested positive for Sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, making this product an unapproved new drug.
Pan Gilori contains Red dye, 45170-Rhodamine B-Basic Violet 10 and silver leaves and other metals at high levels.
Human tissue allografts, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease, were distributed.
The Spanish translation on the Instructions for Use (IFU) insert and product package for hot and cold packs has incorrect heating instructions which would cause product to over heat.
Frozen dog treats recalled due to possible contamination with salmonella due to Sunland Peanut Butter recall
Failed Stability Specifications: The active sunscreen ingredient, avobenzone 3%, may not be stable over the shelf life, the sunscreen effectiveness may be less than labeled.
Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells.
Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals.
The firm is recalling the product due to some cartridges may contain individual discs that are not impregnated with antibiotic. The firm notified their customers of the recall with a notification letter and requested a confirmation fax back of receipt.
The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 133 fire protection mandate required by California and 4 other states.
Blood product, which was collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
Software, with a defect or glitch, was distributed.
Capture-P Indicator Red Cells, with confirmed weaker than expected reactivity with the weak positive control, were distributed.
Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
Contact between the bur and bur guard could generate metal fragments that may or may not be visible to the surgeon and can potentially remain in the surgical site. The materials used to fabricate the bur guard are not traceable, design validation did not effectively evaluate adequate protection of adjacent tissue and inspection results for each of these bur guards were not documented.
Blood Bank software, with a defect or glitch, was distributed.
Blood Bank software, with a defect or glitch possibly causing mislabeling blood products with a donor's CMV status, was distributed.
The firm received two consumer complaints regarding chemical smell/taste and tasting like the can. As a result the firm began extensive testing of its inventory. Preliminary testing identified a contaminant was present. Further testing is pending to specifically identify the contaminant.
ConMed Linvatech recalled one lot of their PopLok bone Punch 3.5mm because the metal shaft diameter is 4.5mm when it should be 3.5mm.
Ortho Pipetter Volume Verification Kit, Lot 0007, mislabeled with the incorrect expiration date, was distributed.
Single lot of Blood Grouping Reagent For Further Manufacturing Use, with a stability test point failure, was distributed.
Meningococcal Oligosaccharide Diphtheria Conjugate Vaccine, with lack of assurance of proper temperature maintenance during shipment, was distributed.
WSI Pride-Plus Amprolium Crumble 1.25% was found to be sub-potent for Amprolium. The sample was detected of 0.9758% instead of 1.25% concentration of Amprolium.
Microbial Contamination of Non-Sterile Products: Product may be contaminated with Burkholderia cepacia.
Standardized Mite Allergenic Extract, mislabeled with the incorrect strength, was distributed.
Presence of Foreign Substance: Tablets are being recalled due to gray defects identified in the tablets.
Bloood product, collected from an ineligible donor, was distributed.
Human Cornea, recovered in a manner that increased the risk of the introduction, transmission, or spread of communicable disease, was distributed.
Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation Crown Cup Connection GXL + 5mm Lateralized Liners Catalog No. (136-32-53). Exactech discovered the device labeling was inadvertently transposed.
The potential exists for the wheel to rotate freely despite engagement of hub brake.
Mama Tere Cebada Flour contains undeclared colors Red #3 and Red #40.
Failed Dissolution Specification: Out of a specification result occurred during the 3-month stability testing. Dissolution result at the 4-hour time point was 41% (specification: 20-40%).
Due to past battery inventory storage conditions and deficiencies in the maintenance procedure, it was possible that some batteries were over-discharged to point of damaging the cells.
Product is dual packaged in an inner and outer pouch, the outer pouch seal may be compromised and sterility may not be assured
Surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter.
Tobii ATI customers P10 external battery pack, which contains sealed lead-acid batteries, malfunctioned while recharging and produced smoke with a chemical smell.
Presence of Foreign Substance: Uncharacteristic blacks spots on tablets.
Defective Container: Pump head detaching from the canister unit upon removal of the overcap.
Tablet/Capsule Imprinted with Wrong ID; a portion of the tablets could contain the incorrect debossing on one side of the tablet U2 instead of U3.
The mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for side indication if the image is mirrored within a PACS system.
A non conformance was identified with one lot of OPTI GEN Food 30 where there is no evidence that a visual inspection was performed on one tray of coverslips,
Missing symbols and manufacturing information on the clear carton label. The expiration dating symbol is missing but the expiration date is not missing. The Lot symbol is missing but the lot number is not missing. The Manufacturer symbol, name and address including country of origin are missing. All of the remaining symbols and information are on the case label. Missing information is only associated with the clear carton label.
Annie's Homegrown was notified by their flour supplier that due to a faulty screen at the flour mill, there is the possibility of metal fragments in some of their pizza products. The USDA was also notified as some of the products fall under their jurisdiction.
Subpotent Drug: OOS (out of specification) assay result at the 12 month stability time point.
Acetobacter lovaniensis was detected in a sample of the product tested by a private laboratory. This is an issue of commercial spoilage.
Lactobacillus plantarum and Lactobacillus brevis were detected in a sample of the product tested by a private laboratory. This is an issue of commercial spoilage.
The tip of the Quadra Trial Broach size 0, broke during a surgery.
The length markings on the Lightspeed LSX files were wrong.
California Department of Public Health sampled Dried Plum Preserves in 4.4 lb packages and found it to contain lead at 1.5 and 1.6 ug/g.
Presence of Foreign Tablets/Capsules: Bottles of lansoprazole 30 mg delayed-release capsules may contain topiramate 100 mg tablets.
Labeling: Incorrect or missing lot and/or expiration date. The product was mistakenly labeled with an expiration date of 10/16 instead of 01/16.
Penzeys received a complaint from a customer who found pieces of glass in bulk Vietnamese Cinnamon.
Imperial Nuts & Snacks brand of Chocolate and Peanut Platter (Net Weight 26 ounces) has undeclared FD&C colors Blue #1, Red #40, Yellow #5 and Yellow #6.
The product contains undeclared sulfites (as a preservative).