The Recall Desk

Archive

July 2014 recalls

688 recalls were announced in July 2014.

What the numbers show

Critical
18
Severe
140
High
292
Moderate
204
Low
34

Of the 688 recalls this month scored against our rubric, 3% are Critical, 20% are Severe.

1–100 of 688

  • SevereNHTSA·14V469000·2014-07-31

    Schwarze M6000SE CNG Street Sweepers Recalled for Fire Risk

    Schwarze is recalling 2009 M6000SE CNG street sweepers because condensation in the intake manifold may freeze, causing sensor failure and potential exhaust fires.

    Product
    SCHWARZE — SCHWARZE M6000SE CNG
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V467000·2014-07-31

    Jayco Recalls 2013-2014 Seneca Motorhomes Due to Fire Risk

    Jayco is recalling 2013-2014 Seneca motorhomes because water infiltration into the entrance door keypad may cause corrosion and an electrical short, increasing the risk of a fire.

    Product
    JAYCO — JAYCO SENECA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V466000·2014-07-31

    Entegra Recalls 2014-2015 Cornerstone Motorhomes for Seat Belt Defect

    Entegra is recalling 2014-2015 Cornerstone motorhomes because incorrect seat belt attachments may cause fraying and reduced strength, increasing injury risk in crashes.

    Product
    ENTEGRA — ENTEGRA CORNERSTONE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V468000·2014-07-31

    Jayco Recalls 2014-2015 White Hawk Travel Trailers Due to Tire Wear

    Jayco is recalling 2014-2015 White Hawk Summit 27RBOK travel trailers because a tire may rub against the outrigger, causing premature wear or failure.

    Product
    JAYCO — JAYCO, JAYCO TRAVEL TRAILER WHITE HAWK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14245·2014-07-31

    Dynacraft Recalls Avigo Youth Bicycles Due to Front Wheel Detachment Hazard

    Dynacraft is recalling Avigo 20-inch youth bicycles because the front wheel can detach, posing a fall hazard. One injury involving scrapes and abrasions has been reported.

    Product
    Avigo 20-inch Turn N' Burn Youth Bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2224-2014·2014-07-30

    PRAN Turmeric Spice Powder Recalled for Excessive Lead Levels

    Ontime Distribution Inc. is recalling PRAN brand Turmeric Spice Powder from New York and New Jersey due to excessive lead levels found by state and federal testing.

    Product
    PRAN brand Spice Powder TURMERIC, Net Wt. 14.1 oz./400g, UPC 8 46656 00209 4, and Net Wt. 8.82 oz./250g, UPC 8 31730 00551 --- PRODUCT OF BANGLADESH -- Manufactured by/Fabricado por: PRAN AGRO LTD, PRAN-RFL Center, 105 Middle Badda, Dhaka-1212, Bangladesh --- This product is pack
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-1446-2014·2014-07-30

    Shamrock Medical Recalls Mislabelled Diltiazem Capsules Packaged as Thiamine

    Shamrock Medical Solutions is recalling Diltiazem HCl capsules that were incorrectly labeled as Thiamine. The error could lead to patients receiving the wrong medication.

    Product
    Taztia XT (Diltiazem HCl) Capsules, 120 mg, Rx, Packaged and labeled as Thiamine. Re-Packaged By: Shamrock Medical Solutions, Lewis Center, Ohio, Mfg: Watson Laboratories, Corona, CA NDC 62037-0696-90
    Category
    Drug
    Distribution
    5 states
  • CriticalFDA (Drugs)·D-1447-2014·2014-07-30

    Oxycodone HCl Oral Concentrate Recalled Due to Incorrect Morphine Labeling

    Shamrock Medical Solutions is recalling Oxycodone HCl Oral Concentrate that was incorrectly labeled as Morphine Sulfate. The product was distributed to Colorado, Massachusetts, Ohio, Texas, and Wyoming.

    Product
    Oxycodone HCl Oral Concentrate, 20 mg/mL, Rx (C-II) Packaged and labeled as Morphine Sulfate 20 mg/mL, Mfg: Lannett Co. Inc., Re-Packaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfr: Cody Laboratories Inc., Cody, WY NDC 00527-1426-36
    Category
    Drug
    Distribution
    5 states
  • SevereNHTSA·14V463000·2014-07-30

    Utility Trailer Recall for Potential Pintle Hook Safety Chain Failure

    Utility Trailer Manufacturing Company is recalling certain 2012-2014 utility trailers because the pintle hook safety chain loop may break, increasing crash risk.

    Product
    UTILITY — UTILITY, UTILITY TRAILER VS1RA, VS2DX, VS2RA, VS3DX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2206-2014·2014-07-30

    Flowers Foods Recalls BBQ Pull-A-Part Bread for Undeclared Milk Allergen

    Flowers Foods is recalling specific brands of BBQ Pull-A-Part Bread because products made with margarine failed to declare milk as an ingredient.

    Product
    BBQ Pull-A-Part Bread (Brands: Sunbeam (UPC 0 77633 05303 1), Bunny (UPC 0 71025 01500 3), Flowers [Foodservice] (UPC 0 72250 01866 1) and Ingles (UPC 0 86854 01543 8), 16oz clear flexible plastic bags, Distributed by Flowers Bakeries, LLC, Thomasville, GA 31757.
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-1464-2014·2014-07-30

    Trinity Care Solutions Recalls Desferal Sterile Compounds Due to Sterility Concerns

    Trinity Care Solutions is recalling Desferal sterile compounds in Florida due to quality control concerns identified during an FDA inspection.

    Product
    Desferal 2 gm/8 mL Sterile Water, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 27767, Discard After 05/23/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1457-2014·2014-07-30

    Trinity Care Solutions Recalls Cefepime Sterile Compounds Due to Sterility Concerns

    Trinity Care Solutions is recalling 24 units of Cefepime 2 gm/100 mL D5W in Florida due to quality control concerns regarding sterility assurance.

    Product
    Cefepime 2 gm/100 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28288, Discard After 02/4/14; Rx # 29176, Discard After 05/21/14; Rx # 28829, Discard After 05/17/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1470-2014·2014-07-30

    Trinity Care Solutions Recalls ANA Kit Due to Sterility Concerns

    Trinity Care Solutions is recalling ANA Kits due to quality control concerns identified during an FDA inspection regarding the assurance of sterility.

    Product
    ANA Kit, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28838, Discard After 03/4/15
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1461-2014·2014-07-30

    Trinity Care Solutions Recalls Meropenem Due to Sterility Concerns

    Trinity Care Solutions is recalling 42 units of Meropenem 1 gm/100 mL 0.9%NS due to lack of assurance of sterility identified during an FDA inspection.

    Product
    Meropenem 1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29087, Discard After 05/28/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1460-2014·2014-07-30

    Trinity Care Solutions Recalls Invanz Due to Sterility Concerns

    Trinity Care Solutions is recalling 12 units of compounded Invanz in Florida due to quality control concerns regarding sterility assurance identified during an FDA inspection.

    Product
    Invanz (ertapenem)1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29157, Discard After 05/19/14; Rx # 29097, Discard After 05/20/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1448-2014·2014-07-30

    Shamrock Recalls Metformin ER Tablets Labeled as Immediate Release

    Shamrock Medical Solutions is recalling metformin ER tablets that were incorrectly labeled as immediate release. The mislabeling could lead to incorrect dosing.

    Product
    metFORMIN ER Tablets, 500 mg, Rx, Packaged and labeled as metFORMIN Immediate Release (IR), Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfr: Amneal/Interpharm, Hauppauge, NY NDC 53746-178-01
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-1479-2014·2014-07-30

    Trinity Care Solutions Recalls Cefepime Due to Sterility Concerns

    Trinity Care Solutions is recalling Cefepime 1 gm/100 mL 0.9%NS due to lack of assurance of sterility identified during an FDA inspection.

    Product
    Cefepime 1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29011, Discard After 05/21/14, Rx # 29141, Discard After 05/22/14, Rx # 29171, Discard After 05/20/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2080-2014·2014-07-30

    Stryker Recalls Disposable StrykeFlow Tips Due to Sterility Concerns

    Stryker Endoscopy is recalling 496 boxes of Disposable StrykeFlow Tips because a deformed blister pouch could compromise the product's sterility.

    Product
    Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip; Sterile, Rx only, Latex Free. Stryker Suction Irrigation system, used to provide a clean and clear operative site through the evacuation and aspiration of irrigant solution. for endoscopic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1469-2014·2014-07-30

    Trinity Care Solutions Recalls Ambisome Due to Sterility Concerns

    Trinity Care Solutions is recalling Ambisome 285 mg/250 mL D5W in Florida due to quality control concerns regarding sterility assurance identified during an FDA inspection.

    Product
    Ambisome 285 mg/250 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28300, Discard After 02/7/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1468-2014·2014-07-30

    Trinity Care Solutions Recalls Normal Saline Syringes Due to Sterility Concerns

    Trinity Care Solutions is recalling Normal Saline 10 mL syringes in Florida due to quality control concerns identified during an FDA inspection.

    Product
    Normal Saline 10 mL/10 mL Syringe, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, Rx # 28839, Discard After 05/5/15; Rx # 29163, Discard After 05/8/15
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Food)·F-2225-2014·2014-07-30

    PRAN Turmeric Spice Powder Recalled for Lead Contamination

    Asia Cash & Carry Inc. is recalling PRAN brand Turmeric Spice Powder because testing found 28 ppm of lead.

    Product
    PRAN brand Spice Powder TURMERIC, Net Wt. 8.82 oz./250g, UPC 8 31730 00551 --- PRODUCT OF BANGLADESH -- Manufactured by/Fabricado por: PRAN AGRO LTD, PRAN-RFL Center, 105 Middle Badda, Dhaka-1212, Bangladesh --- This product is packed in a clear plastic jar with a yellow plastic
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Drugs)·D-1472-2014·2014-07-30

    Trinity Care Solutions Recalls Vancomycin Due to Sterility Concerns

    Trinity Care Solutions is recalling 21 units of Vancomycin 1 gm/100 mL 0.9%NS due to quality control concerns identified during an FDA inspection.

    Product
    Vancomycin 1 gm/100 mL 0.9%NS,Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29186, Discard After 05/22/14; Rx # 29010, Discard After 05/22/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1476-2014·2014-07-30

    Trinity Care Solutions Recalls Compounded Cubicin Due to Sterility Concerns

    Trinity Care Solutions is recalling compounded Cubicin 543 mg/100 mL due to quality control concerns regarding sterility assurance identified during an FDA inspection.

    Product
    Cubicin 543 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29175, Discard After 05/21/14; Rx # 28830, Discard After 05/17/14
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·14V464000·2014-07-30

    Suzuki Recalls 2010-2013 Kizashi Vehicles for Fuel Tank Fire Risk

    Suzuki is recalling 2010-2013 Kizashi vehicles because spider webs may block a fuel system hose, causing a fuel leak and increasing the risk of a fire.

    Product
    SUZUKI — SUZUKI KIZASHI
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1475-2014·2014-07-30

    Trinity Care Solutions Recalls Vancomycin Due to Sterility Concerns

    Trinity Care Solutions is recalling 14 units of Vancomycin 1.25 gm/100 mL 0.9%NS in Florida due to lack of assurance of sterility identified during an FDA inspection.

    Product
    Vancomycin 1.25 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29185, Discard After 05/23/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1482-2014·2014-07-30

    Trinity Care Solutions Recalls Ceftriaxone Due to Sterility Concerns

    Trinity Care Solutions is recalling 12 units of Ceftriaxone 1 gm/50 mL D5W in Florida due to quality control concerns identified during an FDA inspection.

    Product
    Ceftriaxone 1 gm/50 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29190, Discard After 05/23/14, Rx # 29068, Exp 05/18/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1473-2014·2014-07-30

    Trinity Care Solutions Recalls Vancomycin Due to Sterility Concerns

    Trinity Care Solutions is recalling 14 units of Vancomycin 1.25 gm/250 mL due to lack of assurance of sterility identified during an FDA inspection.

    Product
    Vancomycin 1.25 gm/250 mL 0.9%NS,Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29140, Discard After 05/23/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1466-2014·2014-07-30

    Trinity Care Solutions Recalls Cefazolin Due to Sterility Concerns

    Trinity Care Solutions is recalling 21 units of Cefazolin 1 gm/100 mL 0.9%NS in Florida due to quality control concerns regarding sterility assurance.

    Product
    Cefazolin 1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28837, Discard After 04/11/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1478-2014·2014-07-30

    Trinity Care Solutions Recalls Compounded Cubicin Due to Sterility Concerns

    Trinity Care Solutions is recalling compounded Cubicin 700 mg/100 mL due to quality control concerns identified during an FDA inspection.

    Product
    Cubicin 700 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29083, Discard After 05/21/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1455-2014·2014-07-30

    Trinity Care Solutions Recalls Pfizerpen Due to Sterility Concerns

    Trinity Care Solutions is recalling 7 units of Pfizerpen (penicillin G) compounded in Florida due to quality control concerns regarding sterility assurance.

    Product
    Pfizerpen (penicillin G) 24 MU/300 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29183, Discard After 05/21/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1454-2014·2014-07-30

    Trinity Care Solutions Recalls Vancomycin Due to Sterility Concerns

    Trinity Care Solutions is recalling 22 units of Vancomycin 750 mg/100 mL in Florida due to quality control concerns regarding sterility assurance.

    Product
    Vancomycin 750 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28289, Discard After 02/5/14; Rx # 29189, Discard After 05/23/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1459-2014·2014-07-30

    Trinity Care Solutions Recalls Compounded Cubicin Due to Sterility Concerns

    Trinity Care Solutions is recalling 7 units of compounded Cubicin in Florida due to quality control concerns regarding sterility assurance identified during an FDA inspection.

    Product
    Cubicin 486 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, RX # 29038, Discard After 05/20/2014
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1480-2014·2014-07-30

    Trinity Care Solutions Recalls Ceftriaxone Due to Sterility Concerns

    Trinity Care Solutions is recalling 5 units of Ceftriaxone 2 gm/100 mL D5W due to quality control concerns identified during an FDA inspection.

    Product
    Ceftriaxone 2 gm/100 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29150, Discard After 05/17/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1474-2014·2014-07-30

    Trinity Care Solutions Recalls Vancomycin Due to Sterility Concerns

    Trinity Care Solutions is recalling 16 units of Vancomycin 750 mg/150mL D5W due to quality control concerns regarding sterility assurance identified during an FDA inspection.

    Product
    Vancomycin 750 mg/150mL D5W,Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28878, Discard After 05/16/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1456-2014·2014-07-30

    Trinity Care Solutions Recalls Desferal Sterile Compounds Due to Sterility Concerns

    Trinity Care Solutions is recalling Desferal sterile compounds due to quality control concerns identified during an FDA inspection.

    Product
    Desferal 2.5 gm/14 mL Sterile Water, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, Rx # 28314, Discard After 05/22/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1467-2014·2014-07-30

    Trinity Care Solutions Recalls Compounded Cubicin Due to Sterility Concerns

    Trinity Care Solutions is recalling compounded Cubicin 444 mg/100 mL due to quality control concerns regarding sterility assurance identified during an FDA inspection.

    Product
    Cubicin 444 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29114, Discard After 05/13/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1465-2014·2014-07-30

    Trinity Care Solutions Recalls Impipenem/Cilastin Due to Sterility Concerns

    Trinity Care Solutions is recalling 21 units of Impipenem/Cilastin (Primaxin) 500 mg/100 mL due to quality control concerns identified during an FDA inspection.

    Product
    Impipenem/Cilastin (Primaxin) 500 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx #28694, Discard After 05/22/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1462-2014·2014-07-30

    Trinity Care Solutions Recalls Nafcillin Due to Sterility Concerns

    Trinity Care Solutions is recalling Nafcillin 12 gm/300 mL units due to quality control concerns regarding sterility assurance identified during an FDA inspection.

    Product
    Nafcillin 12 gm/300 mL, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29162, Discard After 05/21/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1463-2014·2014-07-30

    Trinity Care Solutions Recalls Unasyn Due to Sterility Concerns

    Trinity Care Solutions is recalling 60 units of Unasyn (ampicillin/sulbactam) in Florida due to quality control concerns regarding sterility assurance.

    Product
    Unasyn (ampicillin/sulbactam) 1.5 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29082, Discard After 05/19/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2021-2014·2014-07-30

    Blood Glucose Test Strips Recalled for Inappropriate Labeling and Marketing

    Diabetic Supply of Suncoast, Inc. is recalling Advocate Redi-Code+ blood glucose test strips because they were inappropriately labeled and marketed.

    Product
    ADVOCATE Redi-Code+ BMB-BA006A Blood Glucose test strips Product Usage: The ADVOCATE¿ Redi-Code+ BMB-BA006A Blood Glucose test strips are used only with the ADVOCATE¿ Redi-Code+ BMB-EA004S meter to quantitatively measure glucose in fresh capillary whole blood samples drawn fr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1453-2014·2014-07-30

    Trinity Care Solutions Recalls Levofloxacin Due to Sterility Concerns

    Trinity Care Solutions is recalling 7 units of compounded Levofloxacin 750 mg/250 mL D5W in Florida due to quality control concerns regarding sterility assurance.

    Product
    Levofloxacin 750 mg/250 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx #29184, Discard After 05/28/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1458-2014·2014-07-30

    Trinity Care Solutions Recalls Ceftriaxone Due to Sterility Concerns

    Trinity Care Solutions is recalling 31 units of Ceftriaxone 2 gm/100 mL 0.9%NS in Florida due to quality control concerns regarding sterility assurance.

    Product
    Ceftriaxone 2 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, RX # 29038, Discard After 05/05/14, & 05/20/14; RX # 29204, Discard After 05/23/14; RX # 29161, Discard After 05/19/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2068-2014·2014-07-30

    GE Healthcare Recalls DateX-Ohmeda S/5 Airway Modules Due to CO2 Measurement Failure

    GE Healthcare is recalling DateX-Ohmeda S/5 Single-Width Airway Modules and E-miniC accessories because a CO2 detector failure may cause incorrect low readings, potentially impairing clinical decision-making for ventilated patients.

    Product
    DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1477-2014·2014-07-30

    Trinity Care Solutions Recalls Compounded Cubicin Due to Sterility Concerns

    Trinity Care Solutions is recalling 8 units of compounded Cubicin 600 mg/100 mL due to quality control concerns regarding sterility assurance.

    Product
    Cubicin 600 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29096, Discard After 05/20/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1481-2014·2014-07-30

    Trinity Care Solutions Recalls Cefepime Due to Sterility Concerns

    Trinity Care Solutions is recalling 11 units of Cefepime 2 gm/100 mL 0.9%NS due to quality control concerns identified during an FDA inspection.

    Product
    Cefepime 2 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28879, Discard After 05/21/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1471-2014·2014-07-30

    Trinity Care Solutions Recalls Tobramycin Syringes Due to Sterility Concerns

    Trinity Care Solutions is recalling 14 units of Tobramycin 300 mg/7.5 mL syringes in Florida due to quality control concerns regarding sterility assurance.

    Product
    Tobramycin 300 mg/7.5 mL Syringe (for Neb), Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28503, Discard After 02/27/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1449-2014·2014-07-30

    Shamrock Medical Recalls Mislabelled Pramipexole Tablets Packaged as Nebivolol

    Shamrock Medical Solutions is recalling Pramipexole Dihydrochloride tablets that were incorrectly labeled as Nebivolol. The error poses a risk of patients receiving the wrong medication.

    Product
    Pramipexole Dihydrochloride Tablets, 0.5 mg, Rx, packaged and labeled to contain Nebivolol tablets, Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfg: Northstar Rx, Memphis, TN NDC 16714-586-01
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Food)·F-2223-2014·2014-07-30

    Fahman Enterprises Recalls Pran Spice Powder Turmeric Due to Lead Levels

    Fahman Enterprises, Inc. is recalling 4 cases of Pran Spice Powder Turmeric due to elevated levels of lead. The product was distributed in the Dallas, Texas area.

    Product
    Pran Spice Powder Turmeric , 14.10 oz. (400g) clear plastic laminated pouch, UPC 8 3173000502 3
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2091-2014·2014-07-30

    Invacare Recalls M41 Wheelchair Controllers Due to Programming Error

    Invacare is recalling 819 M41 powered wheelchair controllers that may cause momentary loss of control due to non-standard factory programming.

    Product
    MK5 NX Controller--Wheelchair controller
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2100-2014·2014-07-30

    Terumo Recalls Sarns Two-stage Venous Return Cannulae Due to Particulate

    Terumo CVS is recalling Sarns Two-stage Venous Return Cannulae because in-process inspections found loose fiber particulate exceeding specifications.

    Product
    Sarns Two-stage Venous Return Cannulae 32/40 & 36/51 Fr with 1/2" & 3/8" flare or connector Product Usage: The Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2198-2014·2014-07-30

    Metagenics Recalls UltraBalance Protein Powder for Undeclared Soy

    Metagenics is recalling UltraBalance Protein Powder because it may contain undeclared soy. The recall covers specific lots distributed nationwide and internationally.

    Product
    UltraBalance Protein Powder, Net Wt. 14.8 oz (420g)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2109-2014·2014-07-30

    Philips QLAB 10 Core Module Software Recall for Measurement Defect

    Philips Ultrasound is recalling QLAB 10 Core Module software due to a defect that may use incorrect measurement values under specific conditions.

    Product
    QLAB 10 Core Module PN 453561704771. QLAB Quantification Software is a software application package designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2082-2014·2014-07-30

    DePuy RECLAIM Taper Protector Sleeve Recalled for Removal Difficulty

    DePuy Orthopaedics is recalling 814 RECLAIM Taper Protector Sleeves because the product can be difficult to remove from the Distal Stem.

    Product
    RECLAIM Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-2111-2014·2014-07-30

    Siemens syngo Imaging XS Software Recall for Potential Miscalculation

    Siemens is recalling syngo Imaging XS software due to potential miscalculation of grey scale values in specific image processing functions.

    Product
    Siemens syngo Imaging XS, version VA70A or higher Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2092-2014·2014-07-30

    Alphatec Spine Recalls Solanas 2.1mm Fixed Depth Drill

    Alphatec Spine is recalling 14 units of the Solanas 2.1mm Fixed Depth Drill because the golden stop slid from its fixed position during use.

    Product
    Solanas 2.1mm FIXED DEPTH DRILL, 10mm, Part No. 63928-10. Component of the SOLANAS III Posterior Stabilization System, a spinal fixation system intended to improve stability of the cervical and thoracolumbar area of the spine (C1-T3).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2115-2014·2014-07-30

    Heartsine AED Electrode Pouches Recalled for Difficulty Opening

    Heartsine is recalling Pad-Pak and Pedi-Pak electrode accessories for the Samaritan PAD 300P and 350P because some sealed foil pouches are difficult to open, potentially delaying therapy.

    Product
    Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P). Automated External Defibrillator electrode supplies. The Pedi-Pak is specifically designed for use with the HeartSine Samaritan PAD 300P and 350P device. It contains d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2079-2014·2014-07-30

    Siemens RAPIDPoint 500 Lactate Cartridges Recalled for Electrolyte Error Codes

    Siemens Healthcare Diagnostics Inc is recalling RAPIDPoint 500 Lactate Cartridges because they may display error codes for electrolyte parameters.

    Product
    RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurement Cartridge Lactate (750 Tests) Part number: 10491449; RAPIDPoint 500 Measurement Cartridge Lactate (400 Tests) Part Number: 10491448 RAPIDPoint 500 Measurement Cartridge Lactate (250 Tests) Part
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2108-2014·2014-07-30

    Teleflex Recalls Hudson RCI Breathing Circuits Due to Temperature Probe Defect

    Teleflex Medical is recalling Hudson RCI breathing circuits because the temperature probe does not properly connect to the temperature port.

    Product
    Hudson RCI, Breathing Circuit, Adult Single Limb (W/Connector, Adaptor, Y Piece), Rx Only, Single Patient Use. The Hudson Heated Wire Ventilator Circuit is intended as a conduit for respiratory gas between a patient and a ventilator, and includes heated wires for use with a Conch
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-2085-2014·2014-07-30

    GE Healthcare CARESCAPE Patient Monitors Recalled for Data Loss

    GE Healthcare is recalling CARESCAPE B850, B650, and B450 patient monitors because the Patient Data Module may fail to communicate, causing partial loss of monitoring parameters.

    Product
    GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2096-2014·2014-07-30

    Terumo Recalls Sarns Venous Return Cannulae Due to Loose Fiber Particulate

    Terumo CVS is recalling Sarns Malleable Dual-stage Venous Return Cannulae because in-process inspections found loose fiber particulate exceeding specifications.

    Product
    Sarns Malleable Dual-stage Venous Return Cannulae 28/38, 32/40 & 34/46 Fr with 1/2" connector with or without Xcoating Product Usage: The Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and infe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2116-2014·2014-07-30

    Pentax Ultrasound Gastroscopes Recalled Due to Aspiration Needle Derailment Risk

    Pentax Medical is recalling 531 ultrasound gastroscopes because aspiration needles may derail from the accessory elevator, posing a risk of patient injury.

    Product
    EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2114-2014·2014-07-30

    GE Healthcare Recalls CARESCAPE Monitor B650 Due to Sound Loss

    GE Healthcare is recalling CARESCAPE Monitor B650 units because they may lose alarm sounds when an external display is connected via a USB extender with an active hub.

    Product
    GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2197-2014·2014-07-30

    Annie Mac's Coconut Macaroons Recalled for Undeclared Allergens

    Annie Mac's Baking Company is recalling Coconut Macaroons because the label fails to declare chocolate, soy lecithin, milk, and sulfur dioxide.

    Product
    Label reads in part "Annie Mac's Baking Co. Coconut Macaroon, "The coconut macaroon is dipped in chocolate, heat sealed in plastic." Net Wt. 12 oz. Product is wrapped in cellophane
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2219-2014·2014-07-30

    Land O'Lakes Recalls Cheese Spread Due to Plastic Contamination

    Land O'Lakes is recalling specific lots of Golden Velvet Pasteurized Process Cheese Spread due to potential contamination with large pieces of plastic.

    Product
    Item: 48775 Land O'Lakes, Golden Velvet Pasteurized Process Cheese Spread - Yellow, NET WT 5 LBS (2.26 KG)
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-2099-2014·2014-07-30

    Terumo Recalls Sarns Soft-Flow Aortic Cannulae Due to Fiber Particulate

    Terumo CVS is recalling Sarns Soft-Flow Aortic Cannulae because in-process inspections found loose fiber particulate exceeding specifications.

    Product
    Sarns Soft-Flow Extended Aortic Cannulae 7.0mm & 8.0mm with or without luer & Xcoating, Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2089-2014·2014-07-30

    Perouse Flamingo Inflation Devices Recalled for Potential Water-Tightness Defect

    Perouse Medical is voluntarily recalling specific batches of Flamingo Inflation Devices due to a potential water-tightness defect that could allow air entry during cardiovascular procedures.

    Product
    Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monitor pressure in the balloon catheter.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-2205-2014·2014-07-30

    Wegmans Ice Bags Recalled Due to Potential Metal Contamination

    Wegmans Food Markets is recalling 7 lb and 18 lb bags of ice because they may contain metal pieces from a broken ice machine part.

    Product
    WEGMANS ICE in plastic bags; NET WT. 7 LBS (UPC 77890 29197) and NET WT 18 LBS (UPC 77890 29200) --- WEGMANS FOOD MARKETS INC. ROCHESTER, NEW YORK
    Category
    Food
    Distribution
    4 states
  • HighNHTSA·14V563000·2014-07-30

    Honda Recalls 2015 Fit Vehicles Due to Incorrect A-Pillar Cover

    Honda is recalling 2015 Fit vehicles because an incorrect A-pillar cover may impair side curtain air bag performance, increasing injury risk in a crash.

    Product
    HONDA — HONDA FIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2094-2014·2014-07-30

    Terumo Recalls Sarns D4 Aortic Arch Cannulae Due to Particulate

    Terumo CVS is recalling Sarns D4 Aortic Arch Cannulae because in-process inspections found loose fiber particulate exceeding specifications.

    Product
    Sarns D4 Aortic Arch Cannulae 6.0mm, 7mm & 8mm angled and straight tip with or without side holes and/or luer Product Usage: The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2098-2014·2014-07-30

    Terumo Recalls Sarns Soft-arc Aortic Cannula Due to Loose Fiber Particulate

    Terumo CVS is recalling 20 units of Sarns Soft-arc Aortic Cannulas because in-process inspections found loose fiber particulate exceeding specifications.

    Product
    Sarns Soft-arc Aortic Cannula 8.0mm curved tip, suture flange, 3/8" flare Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2213-2014·2014-07-30

    Kraft Recalls Knudsen and Other Cottage Cheese Due to Storage Issues

    Kraft Foods is voluntarily recalling multiple cottage cheese brands due to ingredients not being stored at proper temperatures.

    Product
    Cottage Doubles - cottage cheese, 2% milkfat, with blueberry topping sold under the Knudsen brand and packaged in a plastic container with a net weight of 3.9 oz. (110 g).
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2214-2014·2014-07-30

    Kraft Recalls Knudsen and Other Cottage Cheese Due to Temperature Storage Issues

    Kraft Foods is voluntarily recalling multiple cottage cheese brands produced in Tulare, CA, because ingredients were not stored at proper temperatures.

    Product
    Cottage Doubles - cottage cheese, 2% milkfat, with raspberry topping sold under the Knudsen brand and packaged in a plastic container with a net weight of 3.9 oz. (110 g).
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2209-2014·2014-07-30

    Kraft Recalls Cottage Cheese Due to Temperature Storage Violations

    Kraft Foods is voluntarily recalling multiple brands of cottage cheese because ingredients were not stored at proper temperatures, creating a potential safety risk.

    Product
    Cottage cheese, 4% milkfat, sold under the Daily Chef, Knudsen, or Kraft brand and packaged in a plastic container with a net weight of 8 oz. (227 g), a plastic container with a net weight of 16 oz. (1 lb.) 453 g, a plastic container with a net weight of 24 oz. (1.5 lb.) 680 g, a
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2208-2014·2014-07-30

    Kraft Recalls Cottage Cheese Due to Improper Ingredient Storage

    Kraft Foods is voluntarily recalling cottage cheese sold under Breakstone's, Daily Chef, Knudsen, and Kraft brands because ingredients were not stored at proper temperatures.

    Product
    Low fat cottage cheese, 2% milkfat, sold under the Breakstone's brand, Daily Chef brand, Knudsen brand, or Kraft brand packaged in a tray of 4 plastic containers each with a net weight of 4 oz. (113 g), a tray of 8 plastic containers each with a net weight of 4 oz. (113 g), a pla
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2196-2014·2014-07-30

    Country Life Liquid Calcium Magnesium Supplement Recalled for Particulates

    Country Life is recalling specific lots of its liquid calcium and magnesium dietary supplement because the product contains insoluble particulates that do not meet quality standards.

    Product
    Country Life TARGET MINS CALCIUM MAGNESIUM With Vitamin D3 Complex, WILD BLUEBERRY FLAVOR, LIQUID Dietary Supplement, 16 FL. OZ. (1 PINT) (472 mL), Product No. 2523, Bar Code 015794025238, and 32 FL. OZ. (1 QT) (944 mL), Product No. 2522, Bar code 015794025221 --- Manufactured fo
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2218-2014·2014-07-30

    Land O'Lakes Recalls American Cheese Due to Plastic Contamination

    Land O'Lakes is recalling 5 lb blocks of Extra Melt American White cheese due to potential contamination with large pieces of plastic.

    Product
    Item: 4815 Land O'Lakes, Extra Melt American White, Pasteurized Process American Cheese, Net WT 5 lbs (2.26 KG)
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-2097-2014·2014-07-30

    Terumo Recalls Sarns Malleable Venous Return Cannulae Due to Particulate

    Terumo CVS is recalling Sarns Malleable Venous Return Cannulae because in-process inspections found loose fiber particulate exceeding specifications.

    Product
    Sarns Malleable Venous Return Cannulae 24, 28, 30, 32, 34, 36 & 40 Fr single stage with 3/8" & 1/2 flare with or without Xcoating Product Usage: The Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2093-2014·2014-07-30

    Salter Labs Recalls Oxygen Masks Due to Incorrect Labeling

    Salter Labs is recalling 584 units of Model No. 8120-7 oxygen masks because the insert label incorrectly identifies the device as a non-rebreather instead of a partial rebreather.

    Product
    Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentration partial rebreather, with 7 foot (2.1 m) supply tube, Elastic Strap Fixation, Single patient use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2104-2014·2014-07-30

    Terumo Recalls Three-stage Venous Return Cannulae Due to Loose Fiber Particulate

    Terumo Cardiovascular Systems is recalling specific lots of Three-stage Venous Return Cannulae because in-process inspections found loose fiber particulate exceeding specifications.

    Product
    Terumo Three-stage Venous Return Cannulae 28 Fr with 3/8" flare, 30 Fr with 3/8" connector and 30 Fr with 3/8" flare. Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2215-2014·2014-07-30

    Kraft Recalls Knudsen, Breakstone's, and Other Cottage Cheese Brands

    Kraft Foods is voluntarily recalling multiple cottage cheese brands due to ingredients not stored at proper temperatures.

    Product
    Cottage Doubles - cottage cheese, 2% milkfat, with mango topping sold under the Knudsen brand and packaged in a plastic container with a net weight of 3.9 oz. (110 g).
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2106-2014·2014-07-30

    Terumo CPB Catheter Kit Recalled for Loose Fiber Particulate

    Terumo CVS is recalling 125 CPB Catheter Kits because in-process inspections found loose fiber particulate exceeding specifications.

    Product
    CPB Catheter Kit Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2101-2014·2014-07-30

    Terumo Recalls Sarns Venoatrial Cannulae Due to Loose Fiber Particulate

    Terumo CVS is recalling 3,040 Sarns Venoatrial Cannulae units because in-process inspections found loose fiber particulate exceeding specifications.

    Product
    Sarns Venoatrial Cannulae 36/46 Fr with 1/2" flare or connector Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. The Venous Return Cannula is
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2088-2014·2014-07-30

    ITC-Nexus Dx Recalls Hemochron Jr. APTT Cuvettes Due to Test Errors

    ITC-Nexus Dx is recalling Hemochron Jr. APTT cuvettes because they may produce erroneously elevated test results or out-of-range high error codes in non-heparinized blood samples.

    Product
    Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2113-2014·2014-07-30

    Biogenex InSite HER-2 Detection Kit Recalled for Lack of FDA Approval

    Biogenex Laboratories is recalling four InSite HER-2 Detection Kits distributed in Brazil and Ecuador without FDA 510(k) approval.

    Product
    InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2110-2014·2014-07-30

    Philips QLAB 10.1 Software Recalled for Incorrect Measurement Defect

    Philips Ultrasound is recalling QLAB 10.1 software because a defect may cause incorrect measurement values under specific conditions.

    Product
    QLAB 10.1 Core Module PN 453561728001. QLAB Quantification Software is a software application package designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-2102-2014·2014-07-30

    Terumo Dual-stage Venous Return Cannulae Recalled for Loose Fiber Particulate

    Terumo CVS is recalling specific lots of venous return cannulae used in heart surgery due to loose fiber particulate found during inspection.

    Product
    Terumo Dual-stage Venous Return Cannulae 28/38, 29/37, 32/40, 34/46, 36/46 & 36/51 Fr with 1/2" flare or connector Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior ven
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2081-2014·2014-07-30

    AGFA DX-D 100 X-Ray System Recalled for Touch Screen Malfunction

    AGFA Corp. is recalling 216 DX-D 100 digital radiography systems because liquid contact with the touch screen may cause the device to incorrectly recognize user input and alter settings.

    Product
    AGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2086-2014·2014-07-30

    Exactech Recalls NOVATION Femoral Stems Lacking Plasma Coating

    Exactech is recalling 10 NOVATION Femoral Stems because they lack the specified plasma coating. The devices were distributed worldwide.

    Product
    NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be implanted to replace a hip joint with our without bone cement.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2084-2014·2014-07-30

    DePuy RECLAIM Taper Protector Sleeve Recalled for Removal Difficulty

    DePuy Orthopaedics is recalling RECLAIM Taper Protector Sleeves because they can be difficult to remove from the Distal Stem.

    Product
    RECLAIM DISTAL TAPERED Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Food)·F-2207-2014·2014-07-30

    Kraft Recalls Cottage Cheese Due to Temperature Storage Issues

    Kraft Foods is voluntarily recalling Knudsen, Breakstone's, Simply Kraft, and Daily Chef cottage cheese because ingredients were not stored at proper temperatures.

    Product
    Fat free cottage cheese sold under the Knudsen or Kraft brand and packaged in a plastic container with a net weight of 16 oz. (1 lb.) 453 g, a plastic container with a net weight of 24 oz. (1.5 lb.) 680 g, or a plastic container with a net weight of 32 oz. (2 lb.) 907 g.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2107-2014·2014-07-30

    Teleflex Recalls Hudson RCI Breathing Circuits Due to Temperature Probe Defect

    Teleflex Medical is recalling 11,679 Hudson RCI Breathing Circuits because the temperature probe does not properly connect to the temperature port.

    Product
    Hudson RCI, Breathing Circuit, Adult, Single Limb w/Heated Wire, [Respiratory Gas Humidifier, (Direct Patient Interface)]. The Hudson Heated Wire Ventilator Circuit is intended as a conduit for respiratory gas between a patient and a ventilator, and includes heated wires for use
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Food)·F-2212-2014·2014-07-30

    Kraft Recalls Knudsen and Other Cottage Cheese Brands Due to Storage Issues

    Kraft Foods is voluntarily recalling multiple cottage cheese brands produced in Tulare, CA, because ingredients were not stored at proper temperatures.

    Product
    Cottage Doubles - cottage cheese, 2% milkfat, with pineapple topping sold under the Knudsen brand and packaged in a plastic container with a net weight of 3.9 oz. (110 g).
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1450-2014·2014-07-30

    Shamrock Recalls Mislabelled Sulfamethoxazole and Trimethoprim Tablets

    Shamrock Medical Solutions Group LLC is recalling Sulfamethoxazole and Trimethoprim tablets due to a labeling error where 800 mg/160 mg tablets were labeled as 400 mg/80 mg.

    Product
    SULFAMETHOXAZOLE AND TRIMETHOPRIM — SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM)
    Category
    Drug
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-2095-2014·2014-07-30

    Terumo Recalls Sarns Aortic Arch Cannulas Due to Loose Fiber Particulate

    Terumo CVS is recalling 120 units of Sarns Flexible Aortic Arch Cannulas because in-process inspections found loose fiber particulate exceeding specifications.

    Product
    Sarns Flexible Aortic Arch Cannula 8.0mm with luer, 3/8" connector Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2217-2014·2014-07-30

    Kraft Recalls Knudsen and Other Cottage Cheese Brands for Temperature Violations

    Kraft Foods is voluntarily recalling multiple cottage cheese brands produced in California because ingredients were not stored at proper temperatures.

    Product
    Low fat cottage cheese, 1.5% milkfat, with pineapple sold under the Knudsen brand packaged in plastic containers with a net weight of 16 oz. (1 lb.) 453 g.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1451-2014·2014-07-30

    Shamrock Medical Recalls Docusate Calcium Softgels Due to Labeling Error

    Shamrock Medical Solutions is recalling Docusate Calcium Softgel Capsules because they were mislabeled as Docusate Sodium. The error involves a label mix-up for the specific active ingredient.

    Product
    Docusate Calcium Softgel Capsules, 240 mg, OTC, packaged and labeled to contain Docusate Sodium 240mg, Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfg: Major Pharmaceuticals, Livonia, MI NDC 00904-5779-60
    Category
    Drug
    Distribution
    5 states

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