The Recall Desk

Archive

October 2012 recalls

969 recalls were announced in October 2012.

What the numbers show

Critical
242
Severe
210
High
389
Moderate
113
Low
15

Of the 969 recalls this month scored against our rubric, 25% are Critical, 22% are Severe.

201–300 of 969

  • SevereFDA (Food)·F-0379-2013·2012-10-31

    Sunland Peanut Butter Recalled Due to Potential Salmonella Contamination

    Sunland, Inc. is voluntarily recalling specific peanut butter products because they may be contaminated with Salmonella.

    Product
    Sunland Creamy No Stir Peanut Butter, 5 lbs, UPC 4868786704, and 500 lb, UPC 086527. Produced by Sunland Inc, Portales, NM 88130.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0306-2013·2012-10-31

    Justin's Peanut Butter Cups Recalled Due to Salmonella Risk

    Justin's Nut Butter is recalling Organic Dark Chocolate Peanut Butter Cups due to potential Salmonella contamination linked to Sunland, Inc. nut butter products.

    Product
    Organic Dark Chocolate Peanut Butter Cups 1.4 oz, UPC 894455000254.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-026-2013·2012-10-31

    Raritan Pharmaceuticals Recalls Wal-Mucil Fiber Laxative Due to Microbial Contamination

    Raritan Pharmaceuticals is recalling specific lots of Wal-Mucil fiber laxative capsules due to possible C. difficile contamination in the raw material.

    Product
    Wal-Mucil 100% Natural Fiber, 100% Natural Psyllium Seed Husk, Fiber Laxative/Supplement, a)160 capsules per bottle (item #503663), and b) 320 capsules per bottle (Item #586143), Distributed by: Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015-4616, www.walgreens.com, a) UPC 3-
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0328-2013·2012-10-31

    Sunland Recalls Almond, Peanut, and Cashew Butter Products for Salmonella Risk

    Sunland, Inc. is voluntarily recalling specific almond, peanut, and cashew butter products and tahini items because they may be contaminated with Salmonella.

    Product
    Archer Farms Creamy Almond Butter, 16 oz, packed in plastic jars with a plastic screw on lid, UPC 8523902334; stick on labeling is red, green, yellow, and maroon with yellow, red, and black print writing. Distributed by Target Corporation, Minneapolis, MN 55403.
    Category
    Food
    Distribution
    0 states
  • SevereNHTSA·12V529000·2012-10-31

    Dutchmen Recalls 2012-2013 Travel Trailers Due to Missing Furnace Vent

    Dutchmen is recalling 740 model year 2012-2013 travel trailers that may lack an exterior furnace vent, posing carbon monoxide and fire risks.

    Product
    DUTCHMEN — DUTCHMEN, COLEMAN, ASPEN TRAIL ASPEN TRAIL, DUTCHMEN, TRAVEL TRAILER, COLEMAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0151-2013·2012-10-31

    DePuy Mitek Recalls SpiraLok 6.5 Anchors Due to Post-Operative Fracture

    DePuy Mitek is recalling SpiraLok 6.5 anchors because they may fracture after surgery, requiring patients to undergo revision procedures.

    Product
    SpiraLok 6.5 w/out Needles with Orthocord Product Number: 222971 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0148-2013·2012-10-31

    DePuy Mitek Recalls Seven SpiraLok 5.0 Anchors Due to Fracture

    DePuy Mitek is recalling seven SpiraLok 5.0 anchors because they fractured after surgery, requiring patients to undergo revision procedures.

    Product
    SpiraLok 5.0 w/Needles with Orthocord Product Number: 222968 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0153-2013·2012-10-31

    DePuy Mitek Recalls SpiraLok 5.0 Anchors Due to Post-Operative Fracture

    DePuy Mitek is recalling 39,362 units of SpiraLok 5.0 anchors because they may fracture after surgery, requiring revision. The recall covers worldwide distribution.

    Product
    SpiraLok 5.0 w/out Needles with violet and blue Orthocord Product Number: 222986 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0147-2013·2012-10-31

    DePuy Mitek Recalls SPIRALOK Bone Fixation Anchors Due to Fracture

    DePuy Mitek is recalling 66 SPIRALOK bone fixation anchors because they can fracture after surgery, requiring patients to undergo revision surgery.

    Product
    Screw, fixation, boneProduct Number: 222967 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0150-2013·2012-10-31

    DePuy Mitek Recalls Seven SpiraLok 6.5 Anchors Due to Fracture Risk

    DePuy Mitek is recalling seven SpiraLok 6.5 anchors because they fractured after surgery, requiring patients to undergo revision procedures.

    Product
    SpiraLok 6.5 w/Needles with Orthocord Product Number: 222970 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0155-2013·2012-10-31

    DePuy Mitek Recalls SpiraLok Anchors Due to Post-Operative Fracture

    DePuy Mitek is recalling 4,321 units of SpiraLok 6.5 anchors because they may fracture after surgery, requiring revision. The recall covers worldwide distribution.

    Product
    SpiraLok 6.5 w/out Needles with violet and blue Orthocord Product Number: 222988 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0145-2013·2012-10-31

    SpiraLok 5.0mm Anchors Recalled for Post-Operative Fracture Risk

    DePuy Mitek is recalling 232 units of SpiraLok 5.0mm anchors due to post-operative fractures requiring patient revision surgery.

    Product
    SpiraLok 5.0mm with Panacryl without needles Product Number: 222965 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0140-2013·2012-10-31

    DePuy Mitek Recalls SpiraLok Anchors Due to Post-Operative Fracture

    DePuy Mitek is recalling 1,315 units of SpiraLok 5.0mm anchors because they may fracture after surgery, requiring patients to undergo revision procedures.

    Product
    SpiraLok 5.0mm with Ethibond and needles Product Number: 222960 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0442-2013·2012-10-31

    Sunland Peanut Butter Recalled Due to Potential Salmonella Contamination

    Sunland, Inc. is voluntarily recalling specific peanut butter products because they may be contaminated with Salmonella. The recall covers products distributed nationally and in Hong Kong.

    Product
    Natural Value Crunchy Unsalted 100% Organic Peanut Butter, 18 oz, 706173011026.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0461-2013·2012-10-31

    Sunland Recalls Organic Peanut Butter Due to Salmonella Risk

    Sunland, Inc. is voluntarily recalling Sun Harvest Organic Creamy Peanut Butter and other nut butters because they may be contaminated with Salmonella.

    Product
    Sun Harvest Organic Creamy Peanut Butter, 16 oz, UPC 646670304359.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-023-2013·2012-10-31

    Equate Fiber Therapy Recalled for Possible C. Difficile Contamination

    Raritan Pharmaceuticals is recalling Equate Fiber Therapy capsules due to possible C. difficile contamination found in raw materials.

    Product
    Equate Fiber Therapy, 100% Natural Psyllium Husk Fiber, Fiber Laxative/Fiber Supplement, 160 capsules per bottle, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 68163-119-60, UPC 6-81131-77922-7.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0357-2013·2012-10-31

    Sunland Recalls Peanut Butter Products Due to Salmonella Contamination Risk

    Sunland, Inc. is voluntarily recalling specific peanut, almond, and cashew butter products because they may be contaminated with Salmonella.

    Product
    Serious Food... Silly Prices No-Stir Peanut Butter, Creamy, Net Wt. 16 oz, UPC 4792100434, Distributed by Newflower Farmers Market Boulder, CO 80301. Labeling is orange, red, blue, white and yellow with black, orange, white and yellow print writing.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-012-2013·2012-10-31

    Bristol-Myers Squibb Recalls BiCNU Injection Kits Due to Overfilled Vials

    Bristol-Myers Squibb is recalling 31,481 BiCNU kits nationwide and in Puerto Rico because stability testing revealed an overfilled vial in a single lot.

    Product
    BiCNU (Carmustine for injection) 100 mg and Diluent Rx Only BiCNU manufactured by: Ben Venue Laboratories, Inc. Bedford, OH 44146 Diluent manufactured by: Luitpold Pharmaceuticals, Inc. Shirley, NY 11967 Distributed by: Bristol-Meyers Squibb Company Princeton, NJ 08543 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0142-2013·2012-10-31

    DePuy Mitek Recalls SpiraLok Anchors Due to Post-Operative Fracture

    DePuy Mitek is recalling 314 units of SpiraLok 6.5mm anchors because they may fracture after surgery, requiring patients to undergo revision surgery.

    Product
    SpiraLok 6.5mm with Ethibond and needles Product Number: 222962 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0383-2013·2012-10-31

    Sunland Natural Almond Butter Recalled Due to Salmonella Contamination Risk

    Sunland, Inc. is voluntarily recalling specific lots of Natural Almond Butter because they may be contaminated with Salmonella.

    Product
    Sunland Natural Almond Butter, Creamy Roasted Almond, 16 oz UPC 4868772906, Manufactured by: Sunland, Inc. Portales, NM 88130.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0414-2013·2012-10-31

    Sunland Recalls Peanut Butter Products Due to Salmonella Contamination Risk

    Sunland, Inc. is voluntarily recalling specific peanut butter products, including Archer Farms, because they may be contaminated with Salmonella.

    Product
    Archer Farms Creamy Vanilla Cranberry Peanut Butter, 12 oz, UPC 085239020531. Labeling is green, red, and yellow with white and black print writing. Manufactured for Target Corporation Minneapolis, MN 55403.
    Category
    Food
    Distribution
    0 states
  • SevereNHTSA·12V526000·2012-10-31

    Tiffin Allegro Bus Recalled for Exhaust Shielding Defect

    Tiffin Motorhomes is recalling 2010-2013 Allegro Bus motorcoaches due to insufficient exhaust shielding that poses fire and injury risks.

    Product
    TIFFIN — TIFFIN ALLEGRO BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0555-2013·2012-10-31

    General Mills Recalls Cascadian Farm Peanut Butter Granola Bars

    General Mills is recalling specific date codes of Cascadian Farm Organic Peanut Butter Chip Chewy Granola Bars due to potential Salmonella contamination from recalled peanuts.

    Product
    Cascadian Farm Organic peanut butter chip Chewy Granola Bars, 6-1.2 oz (35g) bars, Net Wt 7.4 oz (210g). UPC 21908-14631
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-017-2013·2012-10-31

    Watson Recalls Necon 1/35-28 Tablets Due to Potential Cross-Contamination

    Watson Laboratories is recalling Necon 1/35-28 tablets because certain lots may contain trace amounts of Hydrochlorothiazide (HCTZ). The recall covers 6,466 cartons distributed nationwide and in Puerto Rico.

    Product
    Necon 1/35-28 (norethindrone and ethinyl estradiol) Tablets USP, 1 mg/35 mcg, inert tablets, 28-count tablets per dispenser packaged in 6 Tablet Dispensers per carton, Rx only, Manufactured by: Watson Pharma, Inc., A subsidiary of Watson Pharmaceuticals, Inc., Corona, CA 92880 U
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0404-2013·2012-10-31

    Sunland Organic Valencia Peanut Butter Recalled for Salmonella Contamination Risk

    Sunland, Inc. is voluntarily recalling Organic Valencia Peanut Butter because it may be contaminated with Salmonella. The recall covers products with best-if-used-by dates between May 1, 2011, and September 24, 2013.

    Product
    Sunland Organic Valencia Peanut Butter, Crunchy, 12 oz, UPC 4868731810, produced by Sunland Inc, Portales, NM 88130.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-016-2013·2012-10-31

    Watson Recalls Necon 10/11 Tablets Due to Potential HCTZ Contamination

    Watson Laboratories is recalling specific lots of Necon 10/11 oral contraceptives because they may contain trace amounts of Hydrochlorothiazide (HCTZ).

    Product
    Necon 10/11 (norethindrone and ethinyl estradiol) Tablets USP, 0.5 mg/35 mcg, 1 mg/35 mcg, inert tablets, 28-count tablets per dispenser packaged in 6 Tablet Dispensers per carton, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA; Distributed by: Watson
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0419-2013·2012-10-31

    Sunland Recalls Organic Peanut Butter for Potential Salmonella Contamination

    Sunland, Inc. is recalling Archer Farms Organic Chunky Peanut Butter because the product may be contaminated with Salmonella.

    Product
    Archer Farms Organic Chunky Peanut Butter, 12 oz, UPC 085239020302. Labeling is green, red, and yellow with white and black print writing. Manufactured for Target Corporation Minneapolis, MN 55403.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0154-2013·2012-10-31

    DePuy Mitek Recalls SpiraLok 6.5 Anchors Due to Post-Operative Fracture

    DePuy Mitek is recalling 4,151 units of SpiraLok 6.5 anchors because they may fracture after surgery, requiring revision. The recall covers worldwide distribution.

    Product
    SpiraLok 6.5 w/Needles with violet and blue Orthocord Product Number: 222987 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0360-2013·2012-10-31

    Sunland Recalls Peanut Butter Products Due to Salmonella Contamination Risk

    Sunland, Inc. is voluntarily recalling specific peanut butter products, including Sprouts Farmers Market brand, due to potential Salmonella contamination.

    Product
    Sprouts Farmers Market Creamy Peanut Butter, No Salt, 16 oz, UPC 7487500334, Manufactured Exclusively for Sprouts Farmers Market, Phoenix, Arizona 85028.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-025-2013·2012-10-31

    Raritan Recalls Up&Up Psyllium Fiber Supplement for C. Difficile Contamination

    Raritan Pharmaceuticals is recalling Up&Up Psyllium Fiber Supplement due to possible C. difficile contamination in the raw material.

    Product
    Up&Up Psyllium Fiber Supplement, 100% natural psyllium husk, Fiber Therapy for Regularity/Fiber Supplement, 160 capsules per bottle, Distributed by: Target Corp., Minneapolis, MN 55403, Made in USA, NDC 11673-059-87, UPC 3-68163-11926-8.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0488-2013·2012-10-31

    Sunland Tahini Butter Recalled Due to Potential Salmonella Contamination

    Sunland, Inc. is voluntarily recalling Tahini Butter and other nut butters manufactured between May 2010 and September 2012 due to potential Salmonella contamination.

    Product
    Sunland Tahini Butter, 6 x 5 lb UPC 71704
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0307-2013·2012-10-31

    Justin's Peanut Butter Recalled for Potential Salmonella Contamination

    Justin's Nut Butter is voluntarily recalling certain lots of peanut butter products due to potential Salmonella contamination linked to a supplier recall.

    Product
    Justin's Classic Peanut Butter, 5 lb, Material Number F0004701, 45 lb Material number F0033001.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0351-2013·2012-10-31

    Sunland Recalls Peanut Butter Products Due to Salmonella Contamination Risk

    Sunland, Inc. is voluntarily recalling specific peanut butter products because they may be contaminated with Salmonella. The recall covers products manufactured between May 2010 and September 2012.

    Product
    Peanut Power Butter, Original Formula Net Wt. 16 oz, UPC 5855200003, Manufactured for PB, Inc,. PO BOX 661346, Birmingham, AL 35216. Labeling is black, yellow and white with white, black, yellow and red print writing. Also, Net Wt. 4 lb, UPC 5855200007, Distributed by SNACLite LL
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0412-2013·2012-10-31

    Sunland Recalls Peanut Butter Products Due to Salmonella Contamination Risk

    Sunland, Inc. is voluntarily recalling specific peanut butter products, including Archer Farms Creamy Dark Chocolate Peanut Butter, because they may be contaminated with Salmonella.

    Product
    Archer Farms Creamy Dark Chocolate Peanut Butter, 12 oz, UPC 085239021750. Labeling is green, blue, and yellow with white and black print writing. Manufactured for Target Corporation Minneapolis, MN 65403.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0318-2013·2012-10-31

    Oregon Ice Cream Recalls Chocolate Peanut Butter Ice Cream Due to Salmonella Risk

    Oregon Ice Cream, LLC is recalling 8,830 units of Cascade Glacier Chocolate Peanut Butter ice cream because the peanut butter ingredient is associated with a Sunland, Inc. recall and may be contaminated with Salmonella.

    Product
    Label reads in part "***CASCADE GLACIER CHOCOLATE PEANUT BUTTER ***3 GALLONS (11.36 l) Plant 41-90 DISTRIBUTED BY OREGON ICE CREAM CO. EUGENE OR 97402" upc 0 72609 60082 0.
    Category
    Food
    Distribution
    18 states
  • SevereFDA (Drugs)·D-028-2013·2012-10-31

    Raritan Pharmaceuticals Recalls Fiber Capsules Due to Microbial Contamination

    Raritan Pharmaceuticals is recalling Berkley & Jensen Fiber Capsules due to possible C. difficile contamination found in raw materials.

    Product
    Berkley & Jensen Fiber Capsules, Fiber Laxative/Fiber Supplement, 100% Natural Psyllium Fiber, 400 capsules per bottle, Distributed by: BJWC, 25 Research Drive, Westborough, MA 01581, Made in USA, UPC 4-00016-27053-2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0342-2013·2012-10-31

    Sunland Recalls Peanut Butter Products Due to Salmonella Contamination Risk

    Sunland, Inc. is voluntarily recalling specific peanut butter products because they may be contaminated with Salmonella.

    Product
    Joseph's Salt-Free No Sugar Added New Creamy Valencia Peanut Butter, 18 oz, UPC 3307915072, labeling is orange, white, red, and yellow with red, white, black, and green print writing. Manufactured for: Joseph's Lite Cookies 9422 N. US Hwy 1, Sebastian, FL 32958 USA.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0144-2013·2012-10-31

    DePuy Mitek Recalls SpiraLok 5.0mm Anchors Due to Fracture Risk

    DePuy Mitek is recalling 400 units of SpiraLok 5.0mm anchors because they may fracture after surgery, requiring revision.

    Product
    SpiraLok 5.0mm with Ethibond without needles Product Number: 222964 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0312-2013·2012-10-31

    Jer's Chocolates Recalls Peanut Butter Bars and Squares for Salmonella Risk

    Jer's Chocolates is voluntarily recalling specific lots of peanut butter bars and squares due to potential Salmonella contamination from a supplier.

    Product
    Jer's Squares 16 oz Gable Box, Original/Pretzo, UPC Code 837305006136, Manufactured by Sweet's Candy Company, Salt Lake City, UT.
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Food)·F-0314-2013·2012-10-31

    Pepper Jelly Recalled for Undeclared Milk and Soy Ingredients

    Hanover Pike Enterprises is recalling 1,500 jars of Pepper Jelly because the product contains milk and soy, which are not listed on the label.

    Product
    Pepper Jelly, 4 and 8 ounce jars, labeled in part ***Jill's Jams & Jellies, Hampstead, MD 21074***
    Category
    Food
    Distribution
    16 states
  • SevereFDA (Food)·F-0391-2013·2012-10-31

    Sunland Recalls Peanut Butter Products Due to Salmonella Contamination Risk

    Sunland, Inc. is voluntarily recalling specific peanut butter products because they may be contaminated with Salmonella. The recall covers products distributed nationally and in Hong Kong.

    Product
    Fresh and Easy Goodness Valencia Creamy Peanut Butter, 12/8 1.1 oz, UPC 51379041625, produced for: Fresh and Easy Neighborhood Market, Inc, El Segundo, CA 80245.
    Category
    Food
    Distribution
    0 states
  • HighNHTSA·12V525000·2012-10-31

    General Motors Recalls 2013 Cadillac XTS for Head Restraint Defect

    General Motors is recalling 2013 Cadillac XTS vehicles because rear head restraints may fail to lock upright, increasing neck injury risk in crashes.

    Product
    CADILLAC — CADILLAC XTS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0116-2013·2012-10-31

    Advandx E. coli/P. aeruginosa PNA FISH Kit Recalled for Cross-Reactivity

    Advandx Inc is recalling 33 units of the E. coli/P. aeruginosa PNA FISH kit because Pseudomonas putida strains may cross-react, causing false-positive results.

    Product
    AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identification Kit for Escherichia coli and Pseudomonas aeruginosa Catalog Number : KT007 Usage: E. coli/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for ide
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0311-2013·2012-10-31

    Jer's Chocolates Recalls Peanut Butter Bars and Squares Due to Salmonella Risk

    Jer's Chocolates is voluntarily recalling specific peanut butter products because the peanut butter supplier, Sunland, Inc., is recalling its products due to potential Salmonella contamination.

    Product
    Peanut Butter Bars Cara Mella, 3.0 oz, Two-Bar Box, Caramella, UPC Code 837305005047, Manufactured by Sweet's Candy Company, Salt Lake City, UT; 2) .45 oz., Change Makers, UPC Code 837305005xxx; 3) 4 oz., Gable Box, UPC Code 837305005733
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-0107-2013·2012-10-31

    Westmed Recalls Arterial Blood Gas Kits Due to Contaminated Alcohol Pads

    Westmed is recalling Arterial Blood Gas (ABG) sampling kits because they contain TRIAD brand alcohol pads that are being recalled for potential contaminants.

    Product
    Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, w/Crickett 23g x 1" A Needle, 25U Balanced Heparin, part number: 3373-95. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0113-2013·2012-10-31

    GE Healthcare Recalls innova 3100 Mobile X-ray Systems Due to Filter Failure

    GE Healthcare is recalling 199 innova 3100 mobile X-ray systems due to a potential failure of the spectral filter mechanism inside the collimator.

    Product
    GE Healthcare innova 3100, Mobile X-ray system. The innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally , rotational angiography procedures. They are also i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0131-2013·2012-10-31

    Terumo Recalls Sarns Modular Perfusion System 8000 Due to Power Malfunctions

    Terumo is recalling 81 Sarns Modular Perfusion System 8000 units worldwide due to reported malfunctions in power distribution and battery back-up systems.

    Product
    Perfusion System 8000, base 5 pump, 100V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when us
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-0127-2013·2012-10-31

    Terumo Recalls Sarns Modular Perfusion System 8000 Due to Power Malfunctions

    Terumo Cardiovascular Systems is recalling 1,097 Sarns Modular Perfusion System 8000 units worldwide due to reported malfunctions in power distribution and battery back-up systems.

    Product
    Perfusion System 8000, base 5 pump, 115V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when us
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-0139-2013·2012-10-31

    Encore Medical Recalls 6.5mm Cancellous Bone Screws Due to Labeling Errors

    Encore Medical is recalling 6.5mm Cancellous Bone Screws because some units were mislabeled with incorrect sizes, posing a risk of improper surgical fixation.

    Product
    6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell or fracture repair.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0309-2013·2012-10-31

    Jer's Chocolates Recalls Peanut Butter Bars Due to Salmonella Risk

    Jer's Chocolates is recalling specific peanut butter products because the peanut butter supplier, Sunland, Inc., is recalling its products for potential Salmonella contamination.

    Product
    Peanut Butter Bars Pretzo-Chango: 1) 3.0 oz, Two-Bar Box, UPC Code 837305005030, Manufactured by Sweet's Candy Company, Salt Lake City, UT; 2) 1.5 oz. One-Bar Box, UPC code 837305006242; 3) .45 oz., Change Makers, UPC 837305005825; 4) 4 oz., Gable Box, UPC 837305005771
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-0126-2013·2012-10-31

    Terumo Recalls Sarns Modular Perfusion System 8000 Due to Power Malfunctions

    Terumo Cardiovascular Systems is recalling 274 Sarns Modular Perfusion System 8000 units due to reported malfunctions in power distribution and battery back-up systems.

    Product
    Perfusion System 8000, base 4 pump, 115V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when us
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-0115-2013·2012-10-31

    GE Healthcare recalls innova mobile X-ray systems due to filter failure

    GE Healthcare is recalling 199 innova mobile X-ray systems in the US due to a potential failure of the spectral filter mechanism inside the collimator.

    Product
    GE Healthcare innova 3131-IQ Mobile X-ray system. The innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally , rotational angiography procedures. They are also
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0128-2013·2012-10-31

    Terumo Sarns Modular Perfusion System 8000 Recalled for Power Malfunctions

    Terumo CVS is recalling 466 Sarns Modular Perfusion System 8000 units due to reported power distribution and battery back-up malfunctions.

    Product
    Perfusion System 8000, base 4 pump, 220V/240V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, wh
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Food)·F-0392-2013·2012-10-31

    Sunland Recalls Almond, Peanut, and Cashew Butter Products for Salmonella Risk

    Sunland, Inc. is voluntarily recalling specific almond, peanut, and cashew butter products because they may be contaminated with Salmonella.

    Product
    Harry and David Crunchy Almond and Peanut Butter, 12 oz, Made for: Harry and David, Medford, OR 97501. Labeling is brown, green, and white with black print writing. UPC 8099473873.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0109-2013·2012-10-31

    Westmed Recalls Arterial Blood Gas Kits Due to Alcohol Pad Contaminants

    Westmed is recalling ABG sampling kits because the included TRIAD alcohol pads may contain potential contaminants.

    Product
    Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, w/Crickett 23g x 1" A Needle, 25U Balanced Heparin, part number: 3383-95, 3344-95, 3353-95. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patien
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0310-2013·2012-10-31

    Jer's Chocolates Recalls Peanut Butter Bars Due to Salmonella Risk

    Jer's Chocolates is voluntarily recalling specific peanut butter products because the peanut butter supplier, Sunland, Inc., recalled its products for potential Salmonella contamination.

    Product
    Peanut Butter Bars Toffee: 1) 3.0 oz, Two-Bar Box, Toffee, UPC Code 837305005054, Manufactured by Sweet's Candy Company, Salt Lake City, UT; 2) 4 oz., Gable Box, PC Code 837305005733
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·F-0316-2013·2012-10-31

    Peach Brandy Jam Recalled for Undeclared Milk and Soy Allergens

    Hanover Pike Enterprises is recalling Peach Brandy Jam because it contains undeclared milk and soy ingredients.

    Product
    Peach Brandy Jam, 4 and 9 ounce jars, labeled in part ***Jill's Jams & Jellies, Hampstead, MD 21074***
    Category
    Food
    Distribution
    16 states
  • HighFDA (Devices)·Z-0119-2013·2012-10-31

    Biomet 3i Recalls Dental Implants Due to Missing Internal Threading

    Biomet 3i is recalling 227 Osseotite Tapered Certain Implants because a small percentage are missing internal threading. The devices were distributed worldwide.

    Product
    Osseotite Tapered Certain Implant 5 X 10mm Model INT510 Biomet 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple si
    Category
    Medical Device
    Distribution
    11 states
  • HighNHTSA·12V523000·2012-10-31

    Pierce Contender Fire Trucks Recalled for Engine Software Surge Issue

    Pierce is recalling 2006-2008 Contender fire trucks due to an engine software defect that can cause RPM surges and water pressure fluctuations, potentially leading to injury.

    Product
    PIERCE — PIERCE CUSTOM CONTENDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0069-2013·2012-10-31

    Hospira Symbiq Infusion Pump Recalled for Touchscreen Malfunction

    Hospira is recalling 19,614 Symbiq One Channel Infusion Pumps because the touchscreen may fail to respond or register incorrect values, potentially leading to medication dosing errors.

    Product
    Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; List Number 16026-01 Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0097-2013·2012-10-31

    Westmed Recalls Arterial Blood Gas Kits Due to Contaminated Alcohol Pads

    Westmed is recalling ABG sampling kits containing TRIAD alcohol pads due to potential contaminants in the pads.

    Product
    Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 1 cc, with Eclipse, 25 g x 5/8" A Needle, 25U Balanced Heparin, part number: 3165-98. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0135-2013·2012-10-31

    Nipro AquaLiner Hydrophilic Guidewires Recalled for Insufficient Lubricity

    Nipro Medical Corporation is recalling AquaLiner Hydrophilic Guidewires because insufficient lubricity causes them to get stuck in the housing and become nonfunctional.

    Product
    AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Stiff. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0114-2013·2012-10-31

    GE Healthcare Recalls innova 3100-IQ Mobile X-ray Systems Due to Filter Failure

    GE Healthcare is recalling 199 innova 3100-IQ mobile X-ray systems in the US due to a potential failure of the spectral filter mechanism inside the collimator.

    Product
    GE Healthcare innova 3100-IQ, Mobile X-ray system The innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally , rotational angiography procedures. They are also
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0129-2013·2012-10-31

    Terumo Recalls Sarns Modular Perfusion System 8000 Due to Power Malfunctions

    Terumo Cardiovascular Systems is recalling 312 Sarns Modular Perfusion System 8000 units worldwide due to reported malfunctions in power distribution and battery back-up systems.

    Product
    Perfusion System 8000, base 5 pump, 220V/240V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, wh
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Food)·F-0516-2013·2012-10-31

    Kraft Jalapeno String Cheese Recalled for Potential Choking Hazard

    Kraft Foods is recalling Jalapeno String Cheese because plastic film may remain on the cheese, posing a choking risk.

    Product
    Kraft Jalapeno String Cheese, Net Wt 12 Oz (340 g); a natural low-moisture part-skim mozzarella cheese with jalapeno peppers; 12 individually wrapped 1 oz snacks per 12 oz. bag, 12 bags per case; Distributed by Kraft Foods Global, Inc., Northfield, IL 60093-2753 USA; UPC 0 21000
    Category
    Food
    Distribution
    23 states
  • HighFDA (Devices)·Z-0070-2013·2012-10-31

    Hospira Symbiq Infusion Pump Recalled for Touchscreen Malfunctions

    Hospira is recalling Symbiq Two Channel Infusers because the touchscreen may fail to respond or register incorrect values, potentially causing medication delivery errors.

    Product
    Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; List Number 16027-01 Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0158-2013·2012-10-31

    Sorin Gish Reducer Connectors Recalled for Potential Fluid Leakage

    Sorin Group USA is recalling specific lots of Gish Reducer Connectors due to a molding defect that may cause fluid leaks or air entrainment.

    Product
    Gish 3/8 x 1/2" Reducer Connector with Luer fitting, Item Numbers: EC2180S, Lot Numbers: 1108900099, 1119900091, 1203700129, 1208600013, 1219200107, Exp. Dates: 3/31/14, 7/31/14, 2/28/15, 3/31/15, 7/31/15. Product Usage: The connectors are indicated for use in connecting flex
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0313-2013·2012-10-31

    Hanover Pike Enterprises Recalls Hot Pepper Jelly for Undeclared Allergens

    Hanover Pike Enterprises is recalling 1,500 jars of Hot Pepper Jelly because the product contains undeclared milk and soy ingredients.

    Product
    Hot Pepper Jelly, 4 and 8 ounce jars, labeled in part ***Jill's Jams & Jellies, Hampstead, MD 21074***
    Category
    Food
    Distribution
    16 states
  • HighFDA (Food)·F-0319-2013·2012-10-31

    Buitoni Spinach Ravioli Recalled for Undeclared Shrimp and Lobster Allergens

    Nestle Prepared Foods is recalling Buitoni Spinach & Portobello Mushroom Ravioli because it may contain undeclared shrimp and lobster.

    Product
    BUITONI brand Spinach & Portobello Mushroom All Natural Ravioli, packaged in an 18 oz. bag, frozen UPC code 24842-99186
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0118-2013·2012-10-31

    Elekta Recalls Oncentra External Beam 4.1 Radiation Treatment Planning Software

    Elekta, Inc. is recalling 52 units of Oncentra External Beam 4.1 software due to a defect that allows beam weights to be changed during dose calculation without error messages.

    Product
    Oncentra External Beam 4.1. Radiation treatment planning software designed to analyze and plan radiation treatments in their dimension for the purpose of treating patients with cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0157-2013·2012-10-31

    Sorin Gish Straight Connectors Recalled for Potential Fluid Leakage

    Sorin Group USA is recalling specific lots of Gish straight connectors due to a molding defect that may cause fluid leaks or air entrainment.

    Product
    Gish 3/8 x 3/8" Straight Connector with Luer fitting, Item Numbers: EC2160B, EC2160S, Lot Numbers: 1210100010, 1215100026, 1217000138, Exp. Dates: 4/16/17, 5/31/15, 7/31/15. Product Usage: The connectors are indicated for use in connecting flexible tubing used in extracorpore
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0327-2013·2012-10-31

    General Mills Recalls Nature Valley Almond Granola Bars for Peanut Labeling Error

    General Mills is voluntarily recalling Nature Valley Sweet & Salty Nut Almond granola bars because they may contain peanuts not listed on the label.

    Product
    Individual wrapper: Nature Valley Sweet & Salty Nut, granola bars, Peanut, net WT 1.2 oz (35 g) UPC 0 1600044282 5, Distributed by General Mills Sales, INC., Minneapolis, MN 55440. Ingredients: Roasted Peanuts, High Maltose Corn Syrup......, Mixed Tocopherols Added to Retain Fres
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0125-2013·2012-10-31

    GE Healthcare Recalls Seno Advantage 2.2 Workstations Due to Scale Factor Errors

    GE Healthcare is recalling 12 Seno Advantage 2.2 workstations because inaccurate scale factor annotations may lead to miscalculation of image sizes, potentially impacting patient safety.

    Product
    GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 A medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0121-2013·2012-10-31

    GE Healthcare Recalls Discovery NM/CT 670 and NM 630 Systems

    GE Healthcare is recalling 210 Discovery NM/CT 670 and NM 630 systems due to a potential safety issue where the table pallet may contact the detector during operation.

    Product
    GE Discovery NM/CT670; GE Discovery NM 630 Product Usage: 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0132-2013·2012-10-31

    Biosense Webster MobiCath Bi-Directional Guiding Sheath Recalled for Catheter Interaction

    Greatbatch Medical is recalling MobiCath Bi-Directional Guiding Sheaths due to a potential interaction with therapeutic catheters that may cause them to self-advance.

    Product
    Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the cor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0104-2013·2012-10-31

    Westmed Recalls Arterial Blood Gas Kits Due to Contaminated Alcohol Pads

    Westmed is recalling Pulset ABG sampling kits because they contain TRIAD alcohol pads that are being recalled for potential contaminants.

    Product
    Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, 22 g x 1" A/B Needle, 25U Balanced Heparin, part number: 3372. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0095-2013·2012-10-31

    GE Seno Advantage Workstation Recalled for Incorrect Magnification Measurements

    GE Healthcare is recalling Seno Advantage Workstations because measurement values may be incorrect for magnification images from non-GE digital mammography systems.

    Product
    GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1 Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1: Seno Advantage is a medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a vari
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0130-2013·2012-10-31

    Terumo Recalls Sarns Modular Perfusion System 8000 Due to Power Malfunctions

    Terumo Cardiovascular Systems is recalling 26 units of the Sarns Modular Perfusion System 8000 due to reported malfunctions in power distribution and battery back-up systems.

    Product
    Perfusion System 8000, base 4 pump, 100V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when us
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Drugs)·D-013-2013·2012-10-31

    Watson Recalls Zovia Tablets Due to Potential Cross-Contamination

    Watson Laboratories is recalling Zovia tablets because certain lots may contain trace amounts of Hydrochlorothiazide (HCTZ) due to cross-contamination.

    Product
    Zovia (ethynodiol diacetate and ethinyl estradiol) Tablets USP, 1 mg/35 mcg, inert tablets, 28-count tablets per dispenser packaged in 6 Tablet Dispensers per carton, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA; Distributed by: Watson Pharma, Inc.;
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0098-2013·2012-10-31

    Westmed Recalls Arterial Blood Gas Kits Due to Alcohol Pad Contaminants

    Westmed is recalling Pulset Arterial Blood Gas sampling kits because they contain TRIAD brand alcohol pads that are being recalled for potential contaminants.

    Product
    Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 1 cc, 25 g x 5/8" A Needle, 25U Balanced Heparin, part number: 3173-14. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0136-2013·2012-10-31

    Nipro AquaLiner Hydrophilic Guidewire Recalled for Insufficient Lubricity

    Nipro Medical Corporation is recalling AquaLiner Hydrophilic Guidewires because insufficient lubricity causes them to get stuck in the housing and become nonfunctional.

    Product
    AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Regular. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0117-2013·2012-10-31

    Advanced Bionics Recalls HiRes 90K Cochlear Implants Due to Loose Tools

    Advanced Bionics is recalling 17 HiRes 90K cochlear implant devices with Helix Electrodes because of loose-fitting insertion tool assemblies.

    Product
    HiRes 90K devices with Helix Electrodes Model CI 1400-02H The HiResolution Bionic Ear System is a cochlear implant system designed to provide useful hearing to individuals with severe to profound hearing loss. It consists of internal and external components. The internal compo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0099-2013·2012-10-31

    Westmed Recalls Arterial Blood Gas Kits Due to Alcohol Pad Contaminants

    Westmed is recalling ABG sampling kits containing TRIAD alcohol pads due to potential contaminants in the pads.

    Product
    Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 1 cc, with Eclipse, 25 g x 5/8" A Needle, 25U Balanced Heparin, part number: 3173-98. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0106-2013·2012-10-31

    Westmed Recalls ABG Sampling Kits Due to Contaminated Alcohol Pads

    Westmed is recalling Pulset ABG sampling kits because they contain TRIAD alcohol pads that may have potential contaminants.

    Product
    Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, 23g x 1" A/B Needle, 25U Balanced Heparin, part numbers: 3373, 3393. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0108-2013·2012-10-31

    Westmed Recalls Arterial Blood Gas Sampling Kits Due to Contaminated Alcohol Pads

    Westmed is recalling Pulset Arterial Blood Gas sampling kits because they contain TRIAD brand alcohol pads that are being recalled for potential contaminants.

    Product
    Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, 23g x 1" A Needle w/Eclipse, 25U Balanced Heparin, No CE, part number: 3373-98. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0137-2013·2012-10-31

    Nipro AquaLiner Hydrophilic Guidewires Recalled for Insufficient Lubricity

    Nipro Medical Corporation is recalling AquaLiner Hydrophilic Guidewires because insufficient lubricity causes the wires to get stuck in the housing and become nonfunctional.

    Product
    AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Stiff. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-018-2013·2012-10-31

    Bristol-Myers Squibb Recalls Mispackaged Kombiglyze XR Physician Sample Cartons

    Bristol-Myers Squibb is recalling 117,049 physician sample cartons of Kombiglyze XR because some external cartons were mislabeled with the wrong dosage, though the individual blister units inside are correctly labeled.

    Product
    Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physician Sample-Not For Sale, 6 Tablets per Carton, 2.5 mg/1000 mg, Rx only, Manufactured By: Bristol-Myers Squibb Company, Princeton NJ 08543, USA, Marketed By: Bristol-Myers Squibb Company, Princeton NJ 08
    Category
    Drug
    Distribution
    Distributed nationwide

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