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.

Which agencies issued them

701–800 of 969

  • ModerateFDA (Devices)·Z-0039-2013·2012-10-17

    IDS Urine BETA CrossLaps ELISA Recalled for Incorrect IVD Labeling

    Immunodiagnostics Systems Ltd is recalling IDS Urine BETA CrossLaps ELISA kits because they were labeled for in vitro diagnostic use despite not being registered for that purpose in the US.

    Product
    IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. Type of packaging: Cardboard Box containing plastic bottles. The Urine BETA CrossLaps¿ ELISA is an enzyme immunological test for the quantification of degradation products of C-terminal telopeptides of Type-I collagen in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0048-2013·2012-10-17

    Siemens syngo.plaza Radiological Image Processing System Recall

    Siemens is recalling 11 syngo.plaza systems due to a software defect where archived studies may be missing from the database.

    Product
    Siemens syngo.plaza radiological image processing system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0045-2013·2012-10-17

    IDS-iSYS Intact PINP Control Set Recalled for Incorrect IVD Labeling

    Immunodiagnostics Systems Ltd is recalling 29 units of IDS-iSYS Intact PINP Control Set because they were labeled as In Vitro Diagnostics (IVD) despite not being registered for that use in the US.

    Product
    IDS-iSYS Intact PINP Control Set, Catalog Number IS-4030. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) Control Set is used for quality control of the IDS-iSYS Intact PINP Assay on the IDS-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0016-2013·2012-10-17

    Beckman Coulter Recalls Active Renin IRMA Kit Due to Stability Issues

    Beckman Coulter is recalling the Active Renin IRMA Kit because decreased stability in coated tubes may cause falsely elevated test results.

    Product
    Active Renin IRMA Kit, Part Number DSL25100 Product Usage: The Renin IRMA; DSL25100 immunoradiometric assay kit provides materials for the quantitative measurement of Renin in plasma. This assay is intended for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0042-2013·2012-10-17

    IDS-iSYS Osteocalcin Assay Recalled for Incorrect IVD Labeling

    Immunodiagnostics Systems Ltd is recalling IDS-iSYS N-Mid Osteocalcin assays because they were labeled as In Vitro Diagnostics (IVD) despite not being registered for that use in the US.

    Product
    IDS-iSYS N-Mid¿ Osteocalcin, Catalog Number IS-2900. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS N-Mid¿ Osteocalcin Assay is intended for the quantitative determination of Osteocalcin in human serum or plasma on the IDS-iSYS Multi-Discipline Automated Anal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0035-2013·2012-10-17

    Beckman Coulter Recalls TetraCXP Software for Labeling Updates

    Beckman Coulter is recalling TetraCXP software and CYTO-STAT reagents to update specimen stability claims in the product labeling.

    Product
    TetraCXP Software System, Part Number A40051. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cyto
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0096-2013·2012-10-17

    Da Vinci Pesto Genovese Recalled for Mislabeling Omitted Pine Nuts

    World Finer Foods is recalling Da Vinci Pesto Genovese because pine nuts are listed on the front label but omitted from the ingredient statement.

    Product
    Da Vinci Pesto Genovese with basil and pine nuts Net Wt. 10 oz. (283 g) Distributed by World Finer Foods, Inc. Bloomfield, NJ 07003 Product is packaged in a glass jar with lid. www.worldfiner.com Product of Italy UPC: 0 70670-00822 4
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0050-2013·2012-10-17

    Pacific Northwest Tofu Recalled for Incomplete Soy Labeling

    Pacific Northwest Tofu, LLC is recalling Dae Han Tofu Soya Select Gourmet Firm Tofu because the ingredient list is cut off, partially declaring soy.

    Product
    Gourmet Firm Tofu is packaged in a retail vacuum plastic package and each has net wt. 7.5 oz.. The product is sold under the Dae Han Tofu Soya Select brand. The UPC is 0 34199 718903;
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0025-2013·2012-10-17

    Frozen Farm-Raised Shrimp Recalled for Unapproved Antibiotic Nitrofuran

    Chang Jiang Seafood CA Inc. is recalling frozen farm-raised shrimp because it contains nitrofuran, an unapproved antibiotic.

    Product
    Frozen IQF PND Shrimp (Farm Raised), size 61/70 and size 71/90, 30 lbs (6bgsx5lbs)
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0029-2013·2012-10-17

    Alere Recalls Triage TOX Drug Screen Kits Due to Mislabeled Boxes

    Alere San Diego, Inc. is recalling Triage TOX Drug Screen kits because the boxes containing the test devices were mislabeled.

    Product
    Triage TOX Drug Screen Panel, Model# 94400. Product Usage: The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug and/or the major metabolites above the thre
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0030-2013·2012-10-17

    Siemens Healthcare Recalls Phenobarbital Assay Kits Due to Imprecision

    Siemens Healthcare Diagnostics is recalling specific lots of Emit 2000 and Syva Emit Phenobarbital Assays because they may show higher imprecision when used on Beckman Coulter AU Systems.

    Product
    Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL) Product Usage: Enzyme n Immunoassay, Phenobarbital
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0033-2013·2012-10-17

    Beckman Coulter Recalls CYTO-STAT Reagents Due to Labeling Updates

    Beckman Coulter is recalling CYTO-STAT tetraCHROME reagents because stability claims in the product labeling need to be updated to align with current standards.

    Product
    CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute co
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0044-2013·2012-10-17

    IDS-iSYS Intact PINP Assay Recalled for Incorrect IVD Labeling

    Immunodiagnostics Systems Ltd is recalling IDS-iSYS Intact PINP assays because they were labeled for In Vitro Diagnostic use but are not registered for that purpose in the US.

    Product
    IDS-iSYS Intact PINP, Catalog Number IS-4000. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) assay is intended for the quantitative determination of intact PINP in human serum or plasma on t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0040-2013·2012-10-17

    Immunodiagnostics Systems Recalls IDS-iSYS Ostase BAP Assay Due to Labeling Error

    Immunodiagnostics Systems Ltd is recalling IDS-iSYS Ostase BAP assays because they were labeled for in vitro diagnostic use despite not being registered for that purpose in the US.

    Product
    IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase), Catalog Number IS-2800. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase¿ BAP Assay (IDS-iSYS BAP) is intended for the quantitative determination of bone-specific alkaline phosphatase (BAP), an indicator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-005-2013·2012-10-17

    Actavis Recalls Prometh VC Plain Due to Unknown Degradant

    Actavis Mid Atlantic LLC is recalling Prometh VC Plain bottles because they do not meet stability specifications for an unknown degradant.

    Product
    Prometh VC Plain, Each 5mL contains: Promethazine Hydrochloride 6.25mg & Phenylephrine Hydrochloride 5mg, One Pint Bottles (473mL), Rx Only, Manufactured by: Actavis Mid Atlantic, LLC., 1877 Kawaii Road, Lincolnton, NC, 28092, USA, NDC 0472-1628-16.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0105-2013·2012-10-17

    Mothers' Milk Bank at Austin Recalls Pasteurized Human Milk

    Mothers' Milk Bank at Austin is recalling 54 bottles of pasteurized human milk due to the potential presence of foreign materials.

    Product
    Mother's Milk Bank at Austin, Batch # 9429-1, 3 oz. (100 mL), Pasteurized, Exp: 3/25/2012, KCal/Oz: 20, Protein: .9 g/dl
    Category
    Food
    Distribution
    0 states
  • SevereNHTSA·12V495000·2012-10-12

    Van Hool Recalls 2011-2012 Motorcoaches Due to Alternator Fire Risk

    Van Hool is recalling 138 motorcoaches because missing ground cables on the alternator may cause overheating and a potential vehicle fire.

    Product
    VAN HOOL — VAN HOOL T2145, C2045, T2140
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0007-2013·2012-10-10

    Kerry Organic Soy Protein Isolate Recalled for Salmonella Contamination

    Kerry Foods is recalling Organic Soy Protein Isolate due to potential Salmonella contamination. The product was distributed to Utah.

    Product
    Kerry Organic Pure 900, Organic Soy Protein Isolate, Item #722234.454, packaged in 20-kg. bags. The firm name on the label is Kerry China, Shanghai, China.
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-2442-2012·2012-10-10

    Gills Onions Recalls Slivered Yellow Onions Due to Listeria Risk

    Gills Onions is recalling specific lots of slivered yellow onions because they may be contaminated with Listeria monocytogenes.

    Product
    1/4" Slivered Yellow Onions, 2/5lb, 4/5lb. 1/8" Slivered Yellow Onions, 2/5lb, 4/5lb. 3/16" Slivered Yellow Onions, 2/5lb, 5/2lb, 4/5lb. 3/8" Slivered Yellow Onions, 2/5 lb. 3/8" Slivered Julienne Yellow Onions, 4/5lb.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0014-2013·2012-10-10

    DFI Cantaloupes Recalled Due to Salmonella Contamination

    DFI Marketing Inc. is recalling cantaloupes found positive for Salmonella by USDA testing. The affected melons were distributed nationwide and to Mexico.

    Product
    Cantaloupes are packed in 6ct, 9ct, 12ct, 15ct, 18ct, cardboard cartons with the DFI Brand. "826 California Westside" is also stamped on outside of the carton. Each cantaloupe also has a DFI brand sticker on it.
    Category
    Food
    Distribution
    21 states
  • CriticalFDA (Food)·F-0008-2013·2012-10-10

    JFC Furikake Rice Seasoning Recalled for Undeclared Allergens

    J F C International Inc is recalling JFC Brand Furikake-Seto Fumi rice seasoning due to undeclared eggs, soybeans, and wheat.

    Product
    Furikake (a Japanese rice seasoning of seaweed flakes with toppings/seasonings). JFC Brand Furikake-Seto Fumi, 1.7 oz. Packaged in a clear glass jar with plastic twist lid.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0009-2013·2012-10-10

    Daniella Brand Mangoes Recalled for Potential Salmonella Contamination

    FreshPoint Central California is recalling Daniella brand mangoes due to potential Salmonella Braenderup contamination. The product was distributed in California.

    Product
    Mango Peeled Halved and Cored, wrapped in plastic and refrigerated. Distributed by FreshPoint Central California, Turlock, CA
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-0017-2013·2012-10-10

    Taylor Farms Recalls Wawa Pineapple Due to Salmonella Risk

    Taylor Farms is recalling Wawa pineapple trays because they may contain mangoes contaminated with Salmonella Braenderup or were processed on shared equipment.

    Product
    Wawa pineapple Net Wt. 7 oz (198 g) rigid plastic tray Distributed by: Wawa, Inc. Wawa, PA 19063 UPC 726191069328
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0019-2013·2012-10-10

    Taylor Farms Recalls Wawa Mixed Fruit Due to Salmonella Risk

    Taylor Farms is recalling Wawa mixed fruit trays because they may contain mangoes contaminated with Salmonella Braenderup.

    Product
    Wawa Large mixed fruit Net Wt 12 oz (340 g) in rigid plastic trays Distributed by: Wawa, Inc. Wawa, PA 19063 UPC 726191069250. Wawa Small mixed fruit Net Wt 7.5 oz (213 g) in rigid plastic trays Distributed by: Wawa, Inc. Wawa, PA 19063 UPC 726191069243
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0022-2013·2012-10-10

    Taylor Farms Recalls Wawa Mango and Yogurt Parfaits

    Taylor Farms is voluntarily recalling Wawa mango and yogurt parfaits due to potential Salmonella Braenderup contamination from Daniella Brand mangoes.

    Product
    Wawa mango and yogurt parfait Wt 7.5 oz (213 g) in rigid plastic trays Distributed by: Wawa, Inc. Wawa, PA 19063 UPC 726191070751
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-2441-2012·2012-10-10

    Gills Onions Recalls Slivered Red Onions Due to Listeria Risk

    Gills Onions is recalling specific lots of slivered red onions because they may be contaminated with Listeria monocytogenes.

    Product
    3/16" Slivered Red Onions, 1/5 lb; 1/4" Slivered Red Onions, 2/5lb, 4/5lb;
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2392-2012·2012-10-10

    Pacific Coast Fruit Recalls Fruit Salad Due to Salmonella Risk

    Pacific Coast Fruit Company is recalling VA Kit New Gourmet Fruit Salad because it may be contaminated with Salmonella.

    Product
    VA Kit New Gourmet Fruit Salad 7.75#. Item # 70006, UPC is 0 20728 70006 8. Label reads in part "***VA KIT NEW GOURMET FRUIT SALAD 7.75# *** Ingredients: INGREDIENTS: Watermelon, Honeydew, Cantaloupe, Mangos, Kiwi, Blue Berries. *** Pacific Coast Fruit Portland, OR 97232 **
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-0016-2013·2012-10-10

    Taylor Farms Recalls Wawa Fruit Trays Due to Salmonella Risk

    Taylor Farms is recalling Wawa fruit trays containing mangoes due to potential Salmonella Braenderup contamination.

    Product
    Wawa pineapples, strawberries & mango Net. Wt. 9 oz. rigid plastic tray Distributed by: Wawa, Inc. Wawa, PA 19063 UPC 726191061155
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0015-2013·2012-10-10

    Taylor Farms Recalls Wawa Mangoes Due to Salmonella Risk

    Taylor Farms is recalling Wawa mangoes because they may contain Daniella Brand mangoes contaminated with Salmonella Braenderup.

    Product
    Wawa Mango Net Wt. 8 oz (227 g) Distributed by Wawa, Inc. Wawa, PA 19063 UPC 726191069267
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-2393-2012·2012-10-10

    Pacific Coast Fruit Company Recalls Mango and Cucumber Salsa Due to Salmonella Risk

    Pacific Coast Fruit Company is recalling Mango & Cucumber Salsa because it may be contaminated with Salmonella. The product was distributed to deli retailers in Oregon, Washington, Idaho, and Alaska.

    Product
    Mango & Cucumber Salsa item # 71784 UPC 0 20728 71784 4, Best if Used By July 30 to September 2; Label reads in part "***MANGO 7 CUCUMBER SALSA ***Ingredients: Mangos, English Cucumber, Pineapple Vinaigrette: Vinegar (Cider, Distilled), Water, Soybean Oil, High Fructose corn
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-0020-2013·2012-10-10

    Taylor Farms Recalls Wawa Watermelon Trays Due to Salmonella Risk

    Taylor Farms is voluntarily recalling specific Wawa watermelon trays because they may contain mangoes contaminated with Salmonella Braenderup.

    Product
    Wawa watermelon Net Wt 8 oz (227 g) in rigid plastic trays Distributed by: Wawa, Inc. Wawa, PA 19063 UPC 726191069274
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0018-2013·2012-10-10

    Taylor Farms Recalls Wawa Melon Mix Due to Salmonella Risk

    Taylor Farms is recalling Wawa melon mix because it may contain mangoes contaminated with Salmonella Braenderup.

    Product
    Wawa melon mix Net Wt 11 oz (312 g) in rigid plastic trays Distributed by: Wawa, Inc. Wawa, PA 19063 UPC 726191061148
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0021-2013·2012-10-10

    Taylor Farms Recalls Wawa Mixed Fruit Due to Salmonella Risk

    Taylor Farms is recalling Wawa mixed fruit with kiwi because it may contain mangoes contaminated with Salmonella Braenderup.

    Product
    Wawa mixed fruit with kiwi Net Wt 9.7 oz (275 g) in rigid plastic trays Distributed by: Wawa, Inc. Wawa, PA 19063 UPC 726191069304
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2483-2012·2012-10-10

    Zimmer Recalls Provisional Femoral Heads Due to Fit Issues

    Zimmer, Inc. is recalling MIS 12/14 Slotted Femoral Head Provisional devices because they may fit too loosely or too tightly with mating components.

    Product
    00780303601 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780303602 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780303603 MIS 12/14 Slotted Femoral Head Provisional +3.5X36 00780303604 MIS 12/14 Slotted Femoral Head Provisional +7X36 00780303605 MIS 12/14 Slotte
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0012-2013·2012-10-10

    Dole Sliced Mushrooms Recalled for Potential Listeria Contamination

    Oakshire Mushroom Sales is recalling Dole brand sliced mushrooms due to potential Listeria monocytogenes contamination. The product was distributed to Albertson's.

    Product
    Dole brand Sliced Mushrooms, Net Wt. 8 OZ. (227G), UPC: 0 33383 67600 5, in a plastic container over-wrapped with plastic film. Labeled in part: Dole Sliced Mushrooms, Distributed by Oakshire Mushroom Sales, LLC under license Kennett Square, PA 19348 1-866-355-2077, Product of
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0013-2013·2012-10-10

    Spokane Produce Recalls Champ's Sliced White Mushrooms for Listeria Risk

    Spokane Produce, Inc. is recalling Champ's Sliced White Mushrooms due to potential contamination with Listeria monocytogenes. The product was distributed in six states and to military bases.

    Product
    Champ's Sliced White Mushrooms, 227 g/8 oz, in a styrofoam container with shrink wrap, UPC 0 33383 67600 5. Labeled in part: "CHAMP'S MUSHROOMS Sliced White Mushrooms, Product of Canada, 227g/8 oz, 0 33383 67600 5 KEEP REFRIGERATED
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Devices)·Z-2493-2012·2012-10-10

    Zimmer Recalls Cemented Tibial Drills Due to Bone Perforation Reports

    Zimmer, Inc. is recalling 60 Cemented Tibial Drills for the Persona Personalized Knee System after three reports of tibial cortex perforation during use.

    Product
    Cemented Tibial Drill Product Usage: The cemented tibial drill is used to prepare the tibial bone prior to the impaction of the applicable stemmed tibial broach. The cemented tibial drill has engraved lines that are size specific to guide the user as to the depth to insert th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0011-2013·2012-10-10

    Coast Tropical Brand Whole Mangoes Recalled for Salmonella Risk

    Coast Citrus Dist is recalling 2,630,663 boxes of Coast Tropical Brand Whole Mangoes due to potential Salmonella Branderup contamination.

    Product
    Coast Tropical Brand Whole Mangoes, Kent & Keitt's varieties, 10 lb box. The recalled mangos were sold between July 7, and August 30, 2012 and can be identified by the brand sticker along with one of the following numbers: 3114, 4051, 4311, 4584, and 4959 and the words PRODUCT
    Category
    Food
    Distribution
    22 states
  • SevereFDA (Drugs)·D-004-2013·2012-10-10

    Carefusion Recalls ChloraPrep Skin Preparation Due to Sterility Failure

    Carefusion 213, LLC is recalling ChloraPrep One-Step skin preparation applicators because quarantined material failed sterility testing. The affected product was distributed in Illinois, Missouri, and New Jersey.

    Product
    ChloraPrep One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol) Patient Preoperative Skin Preparation, 3mL Applicators, 25 Applicators per Carton, Single Use, Latex Free, Applicator is STERILE if package is intact, NDC 54365-400-01.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-2482-2012·2012-10-10

    Zimmer Recalls Provisional Femoral Heads Due to Fit Issues

    Zimmer, Inc. is recalling provisional femoral heads used in hip surgery due to reports of sub-optimal fit with mating components.

    Product
    00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 MIS 12/14 Slotted Femoral Head Provisional +0X32 00780303203 MIS 12/14 Slotted Femoral Head Provisional +3.5X32 00780303204 MIS 12/14 Slotted Femoral Head Provisional +7X32 00780303205 MIS 12/14 Slotte
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2481-2012·2012-10-10

    Zimmer Recalls Provisional Femoral Heads Due to Fit Issues

    Zimmer, Inc. is recalling MIS and VerSys provisional femoral heads due to reports of sub-optimal fit with mating components, which can lead to intraoperative dislodging.

    Product
    00780302801 MIS 12/14 Slotted Femoral Head Provisional -3.5X28 00780302802 MIS 12/14 Slotted Femoral Head Provisional +0X28 00780302803 MIS 12/14 Slotted Femoral Head Provisional +3.5X28 00780302804 MIS 12/14 Slotted Femoral Head Provisional +7X28 00780302805 MIS 12/14 Slotte
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2479-2012·2012-10-10

    Zimmer Recalls Provisional Femoral Heads Due to Fit Issues

    Zimmer, Inc. is recalling specific provisional femoral heads used in hip surgery due to reports of improper fit with mating components.

    Product
    00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22 00780302202 MIS 12/14 Slotted Femoral Head Provisional +0X22 00780302203 MIS 12/14 Slotted Femoral Head Provisional +3.5X22 The provisional heads replicate final femoral implant geometry and are used to trial range
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2484-2012·2012-10-10

    Zimmer Recalls Provisional Femoral Heads Due to Fit Issues

    Zimmer, Inc. is recalling provisional femoral heads used in hip surgery due to reports of sub-optimal fit with mating components.

    Product
    00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780304002 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780304003 MIS 12/14 Slotted Femoral Head Provisional +3.5X36 00780304004 MIS 12/14 Slotted Femoral Head Provisional +7X36 00780304005 MIS 12/14 Slotte
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2475-2012·2012-10-10

    Zimmer VerSys Provisional Femoral Heads Recalled for Fit Issues

    Zimmer, Inc. is recalling VerSys provisional femoral heads due to reports of sub-optimal fit with mating components, which can cause intraoperative dislodging.

    Product
    00789502801 VerSys Femoral Head Provisional 28mm -3.5 00789502802 VerSys Femoral Head Provisional 28mm +0 00789502803 VerSys Femoral Head Provisional 28mm +3.5 00789502804 VerSys Femoral Head Provisional 28mm +7 00789502805 VerSys Femoral Head Provisional 28mm +10.5 12/14 Ne
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2480-2012·2012-10-10

    Zimmer Recalls MIS Slotted Femoral Head Provisional Medical Devices

    Zimmer, Inc. is recalling MIS 12/14 Slotted Femoral Head Provisional devices due to reports of sub-optimal fit with mating components, which can lead to intraoperative dislodging.

    Product
    00780302601 MIS 12/14 Slotted Femoral Head Provisional -3.5X26 00780302602 MIS 12/14 Slotted Femoral Head Provisional +0X26 00780302603 MIS 12/14 Slotted Femoral Head Provisional +3.5X26 00780302604 MIS 12/14 Slotted Femoral Head Provisional +7X26 00780302605 MIS 12/14 Slotte
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2476-2012·2012-10-10

    Zimmer Recalls VerSys Provisional Femoral Heads Due to Fit Issues

    Zimmer, Inc. is recalling VerSys provisional femoral heads because they may fit too loosely or too tightly with mating components, posing a risk of intraoperative dislodging.

    Product
    12/14 Neck Taper 00789503201 VerSys Femoral Head Provisional 32mm -3.5 00789503202 VerSys Femoral Head Provisional 32mm +0 00789503203 VerSys Femoral Head Provisional 32mm +3.5 00789503204 VerSys Femoral Head Provisional 32mm +7 00789503205 VerSys Femoral Head Provisional 32
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2449-2012·2012-10-10

    Triple B Recalls Sliced White Mushrooms Due to Listeria Risk

    Triple B Corporation is recalling 8 oz sliced white mushrooms due to potential Listeria monocytogenes contamination. The product was distributed in Idaho, Montana, and Washington.

    Product
    Sliced White Mushroom, Champ's Mushroom, net wt. 8 oz. The UPC is 0 33383 67600 5.
    Category
    Food
    Distribution
    3 states
  • SevereNHTSA·12V491000·2012-10-10

    Toyota Recalls 2007-2009 Models for Power Window Switch Fire Risk

    Toyota is recalling approximately 2.5 million vehicles from 2007-2009 because power window switches may overheat and cause a fire.

    Product
    TOYOTA — TOYOTA, SCION, PONTIAC CAMRY, XD, CAMRY HYBRID, HIGHLANDER HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2444-2012·2012-10-10

    Gills Onions Recalls Diced and Slivered Onions Due to Listeria Risk

    Gills Onions is recalling diced and slivered onions because they may be contaminated with Listeria monocytogenes.

    Product
    1/2" Diced Yellow Onions, 2/5lb, 4/5lb, 20lb. 1/4" Diced Yellow Onions, 1/5 lb, 2/5lb, 4/5lb. 1/8" Diced Yellow Onions, 4/5lb. 3/16" Diced Yellow Onions, 4/5lb. 3/8" Diced Yellow Onions, 1/5lb, 2/5lb, 4/5lb.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0010-2013·2012-10-10

    Daniella Mango Chunks Recalled for Potential Salmonella Contamination

    FreshPoint Central California is recalling Daniella brand mango chunks due to potential Salmonella Braenderup contamination. The product was distributed in California.

    Product
    Mango Chunks, 5# tub Distributed by FreshPoint Central California, Turlock, CA
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2478-2012·2012-10-10

    Zimmer Recalls VerSys Provisional Femoral Heads Due to Fit Issues

    Zimmer, Inc. is recalling VerSys provisional femoral heads because complaints report sub-optimal fit with mating components, leading to intraoperative dislodging.

    Product
    12/14 Neck Taper 00789504001 VerSys Femoral Head Provisional 40mm -3.5 00789504002 VerSys Femoral Head Provisional 40mm +0 00789504003 VerSys Femoral Head Provisional 40mm +3.5 00789504004 VerSys Femoral Head Provisional 40mm +7 00789504005 VerSys Femoral Head Provisional 40
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2474-2012·2012-10-10

    Zimmer Recalls VerSys Provisional Femoral Heads Due to Fit Issues

    Zimmer, Inc. is recalling VerSys provisional femoral heads because they may fit too loosely or too tightly with mating components, posing a risk of intraoperative dislodging.

    Product
    00789502601 VerSys Femoral Head Provisional 26mm -3.5 00789502602 VerSys Femoral Head Provisional 26mm +0 00789502603 VerSys Femoral Head Provisional 26mm +3.5 00789502604 VerSys Femoral Head Provisional 26mm +7 00789502605 VerSys Femoral Head Provisional 26mm +10.5 12/14 Ne
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2473-2012·2012-10-10

    Zimmer Recalls VerSys Provisional Femoral Heads Due to Fit Issues

    Zimmer, Inc. is recalling VerSys provisional femoral heads because they may fit too loosely or too tightly with mating components, posing a risk of intraoperative dislodging.

    Product
    00789502202 VerSys Femoral Head Provisional 22mm +0 00789502203 VerSys Femoral Head Provisional 22mm +3.5 00789502220 VerSys Femoral Head Provisional 22mm -2 00789502230 VerSys Femoral Head Provisional 22mm +3 12/14 Neck Taper The provisional heads replicate final femoral
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0011-2013·2012-10-10

    Philips HeartStart XL Defibrillators Recalled for Battery Failure Risk

    Philips is recalling HeartStart XL Defibrillators used with specific M3516A batteries that may fail without warning, potentially causing the device to shut down unexpectedly during use.

    Product
    Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A batteries The Heart Start XL Defibrillator/Monitor is a fully featured, defibrillator intended for use by qualified medical personnel, trained in either Advanced Cardiac Life Support or in the operation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2477-2012·2012-10-10

    Zimmer Recalls VerSys Provisional Femoral Heads Due to Fit Issues

    Zimmer, Inc. is recalling VerSys provisional femoral heads because they may fit too loosely or too tightly with mating components, posing a risk of intraoperative dislodging.

    Product
    00789503601 VerSys Femoral Head Provisional 36mm -3.5 00789503602 VerSys Femoral Head Provisional 36mm +0 00789503603 VerSys Femoral Head Provisional 36mm +3.5 00789503604 VerSys Femoral Head Provisional 36mm +7 00789503605 VerSys Femoral Head Provisional 36mm +10.5 12/14 Ne
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2443-2012·2012-10-10

    Gills Onions Recalls Diced Red Onions Due to Listeria Risk

    Gills Onions is recalling specific lots of diced red onions because they may be contaminated with Listeria monocytogenes.

    Product
    1/4" Diced Red Onions, 5lb, 2/5lb, 4/5lb; 3/8" Diced Red Onions, 2/5 lb, 4/5lb;
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0006-2013·2012-10-10

    US Endoscopy Raptor Grasping Device Recalled for Potential Jaw Failure

    US Endoscopy Group Inc is recalling 1,153 Raptor grasping devices because the jaws may become stuck open if excessive force is applied while the catheter is coiled.

    Product
    Endoscopic retrieval device. The disposable Raptor grasping device in intended to retrieve foreign bodies or resected tissue specimens in endoscopic procedures of the upper and lower gastrointestinal tract or biliary tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2494-2012·2012-10-10

    Philips Digital Diagnost Patient Carriage Footplate Recall

    Philips is recalling Digital Diagnost patient carriages because the footplate hook may fail, causing the footplate to fall on patients or operators.

    Product
    Philips Digital Diagnost with patient carriage Model: 712050 with serial number range from 00 000 00 to 09 000 543. Product Usage: Stationary radiographic System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2485-2012·2012-10-10

    Biomet Recalls OptiLock Screw Inserters Due to Fit Issues

    Biomet is recalling 268 OptiLock 2.7 mm Screw Inserters because they may not properly lock into screw heads, posing a risk of improper fixation.

    Product
    Optilock 2.7 mm Screw Inserter. Intended Use: The OptiLock Upper Extremity Plating System is intended for fixation of fractures and osteotomies. The System is intended for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus, particularly in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2491-2012·2012-10-10

    Stanley Security Solutions Recalls Tabs Professional Voice + Monitor Units

    Stanley Security Solutions is recalling 4,148 Tabs Professional Voice + Monitor units because the monitor may fail to sound an alarm.

    Product
    Tabs Professional Voice + Monitor, includes one wall bracket, Model 25222. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2492-2012·2012-10-10

    Stanley Security Solutions Recalls Tabs Professional Voice + Monitor Devices

    Stanley Security Solutions is recalling 12,111 Tabs Professional Voice + Monitor units because the monitor may fail to sound an alarm.

    Product
    Tabs Professional Voice + Monitor, with wire bracket, Model 25223. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0002-2013·2012-10-10

    Ocho Rios Jamaican Curry Seasoning Recalled for Undeclared Wheat

    Ocho Rios-Miami, Inc. is recalling 1,100 bottles of Jamaican Curry Seasoning because the label fails to declare whole wheat, a potential allergen.

    Product
    Label reads in part "***OCHO RIOS***Jamaican***Curry***Seasoning***Net Wt. 4 & 8 oz (227 g)***Gold Series***Low Sodium***Extra delicious!***Distributed by :***Ocho Rios International***Miami, Florida 33142***Ingredients: Turmeric,***Fenugreek, Coriander, Cumin***Salt, Anise, Pime
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-2359-2012·2012-10-10

    Cucina Fresca Smoked Tomato Sauce Recalled for Undeclared Milk

    Cucina Fresca, Inc. is recalling Smoked Tomato Sauce because the jars contain a different product with undeclared milk, posing a risk to consumers with milk allergies.

    Product
    Cucina Fresca Smoked Tomato Sauce. Product is packaged in a glass jar, net weight 24 oz. The UPC is 8-84337 00522-4
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2489-2012·2012-10-10

    Stanley Tabs Professional Monitor Recalled for Alarm Failure

    Stanley Security Solutions is recalling 4,749 Tabs Professional Monitors because they may fail to sound an alarm, potentially increasing the risk of falls.

    Product
    Tabs Professional Monitor, without wall bracket, Model 25023. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1070-2012·2012-10-10

    Sadie's Salads Egg Salad Recalled for Undeclared Soybean Oil Allergen

    Sadie's Salads is recalling Egg Salad in 5 lb and 10 lb tubs because the label fails to declare soybean oil, an allergen present in the mayonnaise.

    Product
    Sadie's Salads Egg Salad, 5 lb, 10 lb plastic tubs
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1073-2012·2012-10-10

    Sadie's Salads Cream Slaw Recalled for Undeclared Egg and Soy Allergens

    Sadie's Salads is recalling Old Fashioned Cream Slaw because the label fails to declare egg and soybean oil allergens present in the mayonnaise.

    Product
    Sadie's Salads Old Fashioned Cream Slaw, 5 lb, 10 lb and 30 lb plastic tubs
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0005-2013·2012-10-10

    Ocho Rios Mild Jerk Curry Seasoning Recalled for Undeclared Wheat

    Ocho Rios-Miami, Inc. is recalling Mild Jerk Curry Seasoning because the label fails to declare whole wheat, a major allergen.

    Product
    Label reads in part "***OCHO RIOS***Mild***Jerk***Curry***Seasoning***Extra delicious!***Distributed by :***Ocho Rios International***Miami, Florida 33142***Ingredients: Turmeric,Allspice***Coriander, Fenugreek, Salt, Pepper,***Cumin, Garlic, Onion, Nutmeg,***Cinnamon, Thyme and
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0004-2013·2012-10-10

    Ocho Rios Spicy Jerk Curry Recalled for Undeclared Wheat

    Ocho Rios-Miami, Inc. is recalling Spicy Jerk Curry because whole wheat is not declared on the label.

    Product
    Label reads in part "***OCHO RIOS***Spicy***Jerk***Curry***Distributed by :***Ocho Rios International***Miami, Florida 33142***Ingredients: Turmeric,***Fenugreek, Coriander, Cumin***Salt,*** Anise, Pepper, Pimento, Garlic***Degree of "Heat" 4-Hot***"
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-2446-2012·2012-10-10

    Sadie's Salads Macaroni Salad Recalled for Undeclared Allergens

    Sadie's Salads is recalling Macaroni Salad tubs because the labels fail to declare wheat, soybean oil, and FD&C Yellow #5.

    Product
    Sadie's Salads Macaroni Salad, 5 lb, 10 lb and 30 lb plastic tubs
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2490-2012·2012-10-10

    Stanley Tabs Professional Monitor Recalled for Alarm Failure

    Stanley Security Solutions is recalling 176 Tabs Professional Monitor units because they may fail to sound an alarm, potentially increasing the risk of falls.

    Product
    Tabs Professional Monitor, without pull cord or wall bracket, Model 25025. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0006-2013·2012-10-10

    Boyd Coffee E-3 Seasoning Recalled for Undeclared Soy Allergens

    Boyd Coffee Company is recalling E-3 Seasoning because undeclared soy ingredients were not listed on the label.

    Product
    E-3 Seasoning/Spice, Part #1690. Product is packaged in a white bucket. Net weight 35 lbs. The product is labeled in parts: "***E-3 SEASONING***NET WT 35 LB***Distributed by Boyd Coffee Company, Portland, OR 97230***
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2445-2012·2012-10-10

    Sadie's Salads Potato Salad Recalled for Undeclared Soybean Oil Allergen

    Sadie's Salads is recalling Potato Salad in 5, 10, and 30 lb tubs because the product labeling fails to declare soybean oil, an allergen present in the salad dressing.

    Product
    Sadie's Salads Potato Salad, 5 lb, 10 lb and 30 lb plastic tubs
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2440-2012·2012-10-10

    Sadie's Salads Potato Salad Recalled for Undeclared Allergens

    Sadie's Salads is recalling Red Skin Potato Salad tubs because the labels fail to declare eggs, milk, and soybean oil.

    Product
    Sadie's Salads Red Skin Potato Salad, 5 lb, 10 lb and 30 lb plastic tubs
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0003-2013·2012-10-10

    Ocho Rios Hot Jamaican Curry Recalled for Undeclared Wheat

    Ocho Rios-Miami, Inc. is recalling Hot Jamaican Curry because the label fails to declare whole wheat, a potential allergen.

    Product
    Label reads in part "***OCHO RIOS***Hot***Jamaican***Curry***Gold Series***Extra delicious!***Distributed by :***Ocho Rios International***Miami, Florida 33142***Ingredients: Turmeric,***Fenugreek, Coriander, Cumin, Salt,*** Anise, Pepper, Pimento, Garlic***Degree of "Heat" 4-Hot
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-2486-2012·2012-10-10

    Biomet Recalls OptiLock T15 AO Drivers Due to Fit Issues

    Biomet, Inc. is recalling 363 units of OptiLock T15 AO Drivers because they may not properly lock into specified screw heads.

    Product
    Optilock T15 AO Driver (3.5mm). Intended Use: The OptiLock Upper Extremity Plating System is intended for fixation of fractures and osteotomies. The System is intended for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus, particularly in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2488-2012·2012-10-10

    Stanley Tabs Professional Monitor Recalled for Alarm Failure

    Stanley Security Solutions is recalling 2,754 Tabs Professional Monitors because they may fail to sound an alarm, potentially increasing the risk of falls.

    Product
    Tabs Professional Monitor, includes one wall bracket, Model 25022. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2447-2012·2012-10-10

    Sadie's Salads Macaroni and Cheese Recalled for Undeclared Allergens

    Sadie's Salads is recalling Macaroni and Cheese in 5 lb and 10 lb tubs because the label fails to declare wheat and milk allergens.

    Product
    Sadie's Salads Macaroni and Cheese, 5 lb and 10 lb plastic tubs
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1072-2012·2012-10-10

    Sadie's Salads Broccoli Salad Recalled for Undeclared Allergens

    Sadie's Salads is recalling Broccoli Salad because the label fails to declare egg, milk, and soybean oil allergens.

    Product
    Sadie's Salads Broccoli Salad, 8 lb and 25 lb plastic tubs
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0009-2013·2012-10-10

    Accuro Wound Pro Apex Negative Pressure Wound Therapy Pump Recall

    Accuro Medical Products is recalling 919 Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pumps because they may fail to operate or malfunction without notifying the user.

    Product
    Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC, 2854 Hitchcock Ave, Downers Grove, IL 60515; part number 84635400182, sold inside the Apex Negative Wound Therapy system, part number 84635400181 Promotes wound healing through dr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0003-2013·2012-10-10

    Beckman Coulter Recalls IMMAGE Rheumatoid Factor Reagent Due to False Results

    Beckman Coulter is recalling specific lots of IMMAGE Rheumatoid Factor reagent because they may produce false abnormal results in patient samples.

    Product
    IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, PN 447070 The IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) reagent, in conjunction with Beckman Cal 5 Plus, is intended for use in the quantitative determination of human rheumatoid factor concentrations i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2487-2012·2012-10-10

    Stryker Orthopaedics Recalls Cone Body Trials Due to Metal Shavings

    Stryker Howmedica Osteonics Corp. is recalling 10,983 Restoration Modular Cone Body Trials because metal shavings were found in the internal threaded portion.

    Product
    Stryker Orthopaedics Restoration Modular Cone Body Trials Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland. The Cone Body Trials simulate the respective Cone Body implants and mate with the stem trials to assist the surgeon in assessing the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0004-2013·2012-10-10

    Cure Medical Recalls M16 Straight-Tip Intermittent Urinary Catheters Due to Labeling Error

    Cure Medical LLC is recalling M16 straight-tip intermittent urinary catheters because some intermediate boxes are mislabeled as M16C coudé-tip catheters.

    Product
    Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). There are 30 catheters packaged in sterile pouches that
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0010-2013·2012-10-10

    C.R. Bard Recalls Pediatric Foley Catheters with Incorrect Valve Cap Labeling

    C.R. Bard is recalling 4,032 units of 8 Fr. Bardex Pediatric All-Silicone Foley Catheters because the valve cap displays an incorrect inflation volume of 10 ml instead of 5 ml.

    Product
    8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder.
    Category
    Medical Device
    Distribution
    Distributed nationwide

Looking for a different month? Back to 2012.