The Recall Desk

Archive

July 2013 recalls

741 recalls were announced in July 2013.

What the numbers show

Critical
104
Severe
276
High
229
Moderate
107
Low
25

Of the 741 recalls this month scored against our rubric, 14% are Critical, 37% are Severe.

501–600 of 741

  • SevereFDA (Drugs)·D-644-2013·2013-07-10

    Clinical Specialties Compounding Pharmacy Recalls HCG Syringes Due to Sterility Concerns

    Clinical Specialties Compounding Pharmacy is recalling HCG 2000 units/ml syringes because FDA inspection findings raised concerns about quality control and assurance of sterility.

    Product
    HCG 2000 units/ml, 30 mL syringe, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-637-2013·2013-07-10

    Cyclosporine 2% Ophthalmic Recalled Due to Sterility Concerns

    Clinical Specialties Compounding Pharmacy is recalling Cyclosporine 2% ophthalmic due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Cyclosporine 2% ophthalmic, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1661-2013·2013-07-10

    DJO VenaFlow Elite Compression Pump Recalled for Battery Fire Risk

    DJO, LLC is recalling VenaFlow Elite 30B-B and 30BI-B compression pumps due to a potential battery leakage issue that could cause a fire.

    Product
    VenaFlow Elite 30B-B and 30BI-B Product Usage: The VenaFlow Elite System is a compression pump used for the prevention of Deep Vein Thrombosis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V305000·2013-07-10

    Keystone Laredo Fifth Wheel Recall for Battery Box Support Defect

    Keystone RV is recalling 2013-2014 Laredo Fifth Wheel vehicles because the battery box may fall out of position, creating a fire or road hazard.

    Product
    KEYSTONE — KEYSTONE LAREDO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-655-2013·2013-07-10

    Clinical Specialties Compounding Pharmacy Recalls Methylcobalamin Due to Sterility Concerns

    Clinical Specialties Compounding Pharmacy is recalling specific lots of Methylcobalamin 12.5 mg/ml because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Methylcobalamin 12.5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Food)·F-1587-2013·2013-07-10

    Hannaford Oatmeal Raisin Cookies Recalled for Undeclared Tree Nuts

    Delhaize America is recalling Hannaford Gourmet Oatmeal Raisin Cookies because they may contain undeclared tree nuts. The product was sold in five northeastern states.

    Product
    Hannaford Gourmet Oatmeal Raisin Cookies (9 oz. package) UPC # 0004126872715
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Drugs)·D-675-2013·2013-07-10

    Clinical Specialties Compounding Pharmacy Recalls Test Cyp 50 mg-estradiol cyp 2 mg/ml

    Clinical Specialties Compounding Pharmacy is recalling specific lots of Test Cyp 50 mg-estradiol cyp 2 mg/ml due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Test Cyp 50 mg-estradiol cyp 2 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-636-2013·2013-07-10

    Cyclosporine 1% Ophthalmic Drops Recalled for Sterility Concerns

    Clinical Specialties Compounding Pharmacy is recalling specific lots of Cyclosporine 1% ophthalmic drops due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Cyclosporine 1% ophthalmic drops, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1656-2013·2013-07-10

    HealthLink Recalls Biopsy Punches Due to Lack of Sterilization

    Clorox Healthcare Holdings is recalling 772,600 units of Argent Surgical Systems Biopsy Punches because they were not sterilized.

    Product
    ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-657-2013·2013-07-10

    Clinical Specialties Compounding Pharmacy Recalls Mitomycin Solution Due to Sterility Concerns

    Clinical Specialties Compounding Pharmacy is recalling specific lots of Mitomycin (modified) 0.02% solution because FDA inspection findings raised concerns about quality control processes and assurance of sterility.

    Product
    Mitomycin (modified) 0.02% solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-626-2013·2013-07-10

    Baxter Recalls Heparin Sodium Injection Due to Sterility Concerns

    Baxter Healthcare is recalling specific lots of Heparin Sodium in Sodium Chloride Injection due to a manufacturing defect that may compromise sterility.

    Product
    HEPARIN SODIUM IN SODIUM CHLORIDE — HEPARIN SODIUM IN SODIUM CHLORIDE (HEPARIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-654-2013·2013-07-10

    Methylcobalamin Injection Recalled for Sterility Concerns

    Clinical Specialties Compounding Pharmacy is recalling Methylcobalamin 1250 mcg/ml injections due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    Methylcobalamin 1250 mcg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-669-2013·2013-07-10

    Clinical Specialties Compounding Pharmacy Recalls Test Cyp 250 mg-lidocaine 5 mg/ml

    Clinical Specialties Compounding Pharmacy is recalling Test Cyp 250 mg-lidocaine 5 mg/ml due to lack of assurance of sterility identified during an FDA inspection.

    Product
    Test Cyp 250 mg-lidocaine 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-645-2013·2013-07-10

    FDA Recalls HCG Syringes Due to Sterility Concerns

    Clinical Specialties Compounding Pharmacy is recalling HCG 500 units/ml syringes distributed in Florida, Georgia, and South Carolina due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    HCG 500 units/ml, 10 mL syringe, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-660-2013·2013-07-10

    Clinical Specialties Compounding Pharmacy Recalls Pap 300 mg-phent 10 mg-prost 100 mcg

    Clinical Specialties Compounding Pharmacy is recalling specific lots of Pap 300 mg-phent 10 mg-prost 100 mcg due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Pap 300 mg-phent 10 mg-prost 100 mcg, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-656-2013·2013-07-10

    Mitomycin 0.04% Solution Recalled Due to Sterility Concerns

    Clinical Specialties Compounding Pharmacy is recalling specific lots of Mitomycin 0.04% solution due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    Mitomycin 0.04% solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-662-2013·2013-07-10

    Progesterone Injection Recalled Due to Sterility Concerns

    Clinical Specialties Compounding Pharmacy is recalling specific lots of Progesterone 50 mg/ml because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Progesterone 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-640-2013·2013-07-10

    Estradiol Valerate Injection Recalled Due to Sterility Concerns

    Clinical Specialties Compounding Pharmacy is recalling Estradiol Valerate 20 mg/ml injections due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    Estradiol Valerate 20 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-663-2013·2013-07-10

    Sodium Chloride Recall Due to Sterility Concerns

    Clinical Specialties Compounding Pharmacy is recalling Sodium Chloride (23.4%) due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    Sodium Chloride (23.4%), Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Food)·F-1589-2013·2013-07-10

    General Mills Recalls Cinnamon Toast Crunch Bowls Due to Salmonella Risk

    General Mills is recalling specific single-serve Cinnamon Toast Crunch bowls sold in foodservice establishments because an ingredient may contain salmonella.

    Product
    General Mills, Cinnamon Toast Crunch, 25% Less Sugar, Self-Serve Bowl, Net WT 1.0 oz ( 28g), Distributed by General Mills Sales, Minneapolis, MN 55440, Package UPC 00016000294448. Case: General Mills, BOWLPAK, Cinnamon Toast Crunch, Reduced Sugar, 96 - 1 oz (28g)…
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Drugs)·D-661-2013·2013-07-10

    Phenylephrine-cyclopentolate recalled due to lack of assurance of sterility

    Clinical Specialties Compounding Pharmacy is recalling Phenylephrine-cyclopentolate due to FDA inspection findings regarding quality control and sterility.

    Product
    Phenylephrine-cyclopentolate, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Food)·F-1586-2013·2013-07-10

    Butterfly Bakery Harvest Berry Muffins Recalled for Undeclared Walnuts

    Butterfly Bakery Inc. is recalling Harvest Berry Muffins because they may contain undeclared walnuts, a major food allergen.

    Product
    Butterfly Bakery Harvest Berry Muffins (four muffins per package) Net. Wt. 14.5 OZ (410 g) UPC 6 43482 60014 8 Manufactured by: Butterfly Bakery Inc.200 Clifton Boulevard, Clifton, NJ 07013 T: 973.815.1501 Packaged in a plastic clam shell.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-680-2013·2013-07-10

    Vancomycin Recall Due to Sterility Concerns at Compounding Pharmacy

    Clinical Specialties Compounding Pharmacy is recalling Vancomycin 50 mg/ml due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    Vancomycin 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-642-2013·2013-07-10

    Gentamicin Buffered Recall Due to Sterility Concerns

    Clinical Specialties Compounding Pharmacy is recalling Gentamicin buffered 36.4 mg/ml due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    Gentamicin buffered 36.4 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-674-2013·2013-07-10

    Clinical Specialties Compounding Pharmacy Recalls Test Cyp 50 mg-estradiol cyp 2 mg/ml

    Clinical Specialties Compounding Pharmacy is recalling Test Cyp 50 mg-estradiol cyp 2 mg/ml due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Test Cyp 50 mg-estradiol cyp 2 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-628-2013·2013-07-10

    Baxter Recalls Sodium Chloride Injection Due to Sterility Concerns

    Baxter Healthcare is recalling specific lots of Sodium Chloride Injection due to a manufacturing defect that may compromise sterility.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-666-2013·2013-07-10

    Clinical Specialties Compounding Pharmacy Recalls Test Cyp 200 mg/ml Due to Sterility Concerns

    Clinical Specialties Compounding Pharmacy is recalling Test Cyp 200 mg/ml because FDA inspections raised concerns about quality control and sterility assurance. The product was distributed in Florida, Georgia, and South Carolina.

    Product
    Test Cyp 200 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-632-2013·2013-07-10

    Clinical Specialties Compounding Pharmacy Recalls Acetylcysteine 10% Solution

    Clinical Specialties Compounding Pharmacy is recalling Acetylcysteine 10% Solution due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Acetylcysteine 10 % Solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-679-2013·2013-07-10

    Tetracaine Solution Recalled for Sterility Concerns

    Clinical Specialties Compounding Pharmacy is recalling Tetracaine 0.25% solution due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    Tetracaine(buffered) 0.25% solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1647-2013·2013-07-10

    Ortho-Clinical Diagnostics Recalls VITROS 5,1 FS Chemistry Systems Due to Electrical Short

    Ortho-Clinical Diagnostics is recalling 101 VITROS 5,1 FS Chemistry Systems because an electrical short can cause heat accumulation and melted wiring.

    Product
    1) VITROS 5,1 FS Chemistry System (product code 6801375) and 2) VITROS 5,1 FS Chemistry System Refurbished (product code 6801890) Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-658-2013·2013-07-10

    Clinical Specialties Compounding Pharmacy Recalls Ophthalmic Dilation Gel

    Clinical Specialties Compounding Pharmacy is recalling ophthalmic dilation gel due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Ophthalmic dilation gel, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereNHTSA·13V307000·2013-07-10

    Honda Recalls 2014 CTX700 Motorcycles for ABS Malfunction Risk

    Honda is recalling 2014 CTX700 motorcycles because a manufacturing error may cause the Anti-Lock Brake System to malfunction, increasing the risk of a crash.

    Product
    HONDA — HONDA CTX700
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1663-2013·2013-07-10

    Siemens Linear Accelerator Recall Due to Potential Patient Mistreatment

    Siemens is recalling specific linear accelerator systems because a difficult-to-interpret calibration issue may have resulted in the mistreatment of cancer patients.

    Product
    Siemens MEVATRON series, PRIMART (limited release)PRIMUS and/or ONCOR or ARTIST Linac Systems with BEAMVIEW capability. The intended use of the SIEMENS branded MEVATRON", ARTISTE", ONCOR" and PRIMUS" family of linear accelerator systems is to deliver X-ray photon and electron…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-677-2013·2013-07-10

    Clinical Specialties Compounding Pharmacy Recalls Test Cyp 50 mg-estradiol Blend

    Clinical Specialties Compounding Pharmacy is recalling Test Cyp 50 mg-estradiol blend 22 mg due to lack of assurance of sterility.

    Product
    Test Cyp 50 mg-estradiol blend 22 mg, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-643-2013·2013-07-10

    Clinical Specialties Compounding Pharmacy Recalls HCG Syringes Due to Sterility Concerns

    Clinical Specialties Compounding Pharmacy is recalling HCG 1000 units/ml syringes due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    HCG 1000 units/ml, 30 mL syringe, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-668-2013·2013-07-10

    Clinical Specialties Compounding Pharmacy Recalls Testosterone and Estradiol Injection

    Clinical Specialties Compounding Pharmacy is recalling a specific lot of Test cyp 25 mg-Estradiol cyp 5 mg/ml injection due to lack of assurance of sterility.

    Product
    Test cyp 25 mg-Estradiol cyp 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-633-2013·2013-07-10

    Acetylcysteine 20% Solution Recalled Due to Sterility Concerns

    Clinical Specialties Compounding Pharmacy is recalling Acetylcysteine 20% solution due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Acetylcysteine 20 % solution, 100 ml bottle, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-639-2013·2013-07-10

    Estradiol Cypionate Injection Recalled Due to Sterility Concerns

    Clinical Specialties Compounding Pharmacy is recalling Estradiol Cypionate 5 mg/ml injections due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    Estradiol Cypionate 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1620-2013·2013-07-10

    Zimmer Recalls Fukuda Retractors Due to Fractures During Surgery

    Zimmer, Inc. is recalling Fukuda retractors because they fracture at the grooves during use. The recall includes 722 units distributed worldwide.

    Product
    Bigliani/Flatow¿ The Complete Solution Fukuda Retractors Large Nonsterile 4305-19-40. Used in retracting the humeral shaft posteriorly and exposing the entire glenoid surface.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-659-2013·2013-07-10

    Clinical Specialties Compounding Pharmacy Recalls Ophthalmic Dilation Gel

    Clinical Specialties Compounding Pharmacy is recalling ophthalmic dilation gel due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Ophthalmic dilation gel (MAR), Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-649-2013·2013-07-10

    Clinical Specialties Compounding Pharmacy Recalls Laser Ophthalmic Drops

    Clinical Specialties Compounding Pharmacy is recalling specific lots of laser ophthalmic drops due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    Laser ophthalmic drops, 12 mL bottle, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1621-2013·2013-07-10

    Zimmer Recalls Fukuda Retractors Due to Fracture Risk During Surgery

    Zimmer, Inc. is recalling Fukuda-type retractors because they may fracture at the grooves during surgical use. This recall expands a 2010 action to include seven additional lots.

    Product
    Bigliani/Flatow¿ The Complete Solution Fukuda Retractors Small Nonsterile 00-4305-019-30. Used in retracting the humeral shaft posteriorly and exposing the entire glenoid surface.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1648-2013·2013-07-10

    Ortho-Clinical VITROS 4600 Chemistry System Recalled for Electrical Short

    Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems because an electrical short in the connector caused heat accumulation and melted wiring.

    Product
    VITROS 4600 Chemistry System (VITROS 5,1 FS System family member)(product code 6802445) Product Usage: For use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-653-2013·2013-07-10

    Clinical Specialties Compounding Pharmacy Recalls Methionine/Choline/Inositol/B-12 Injection

    Clinical Specialties Compounding Pharmacy is recalling Methionine/Choline/Inositol/B-12 products due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Methionine/Choline/Inositol/ B-12, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-652-2013·2013-07-10

    Medroxyprogesterone Injection Recalled Due to Sterility Concerns

    Clinical Specialties Compounding Pharmacy is recalling Medroxyprogesterone 50 mg/ml injections due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    Medroxyprogesterone 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1649-2013·2013-07-10

    Ortho-Clinical VITROS 5600 Integrated System Recalled for Electrical Short

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems due to an electrical short that caused heat accumulation and melted wiring.

    Product
    VITROS 5600 Integrated System (product code 6802413) Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1651-2013·2013-07-10

    Ortho Assay Software Server Recalled Due to Electrical Short and Heat

    Ortho-Clinical Diagnostics is recalling 31 units of the ORTHO Assay Software Server because an electrical short caused heat accumulation and melted wiring.

    Product
    ORTHO¿ Assay Software (OAS) Server, Catalog # 6842840 Usage: The ORTHO¿ Summit System (OSS) is a modular, integrated system for use with licensed blood screening tests. Consisting of networked processors and instruments linked together via a local area network…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1650-2013·2013-07-10

    Ortho-Clinical VITROS 3600 Immunodiagnostic System Recalled for Electrical Short

    Ortho-Clinical Diagnostics is recalling VITROS 3600 Immunodiagnostic Systems because an electrical short caused heat accumulation that melted wiring and connectors.

    Product
    VITROS 3600 Immunodiagnostic System (product code 6802783) Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1588-2013·2013-07-10

    Hannaford Gourmet Cookie Platters Recalled for Undeclared Tree Nuts

    Hannaford Gourmet Cookie Platters are being recalled because they may contain undeclared tree nuts, posing a risk to consumers with allergies.

    Product
    Hanna ford Gourmet Cookie Platter (36 oz. package), Includes oatmeal raisin cookies UPC # 04126874662
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Drugs)·D-625-2013·2013-07-10

    Baxter Recalls 5% Dextrose Injection Due to Sterility Concerns

    Baxter Healthcare is recalling specific lots of 5% Dextrose Injection due to a manufacturing defect that may compromise sterility.

    Product
    DEXTROSE — DEXTROSE (DEXTROSE MONOHYDRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-634-2013·2013-07-10

    Acetylcysteine 2% Solution Recalled Due to Sterility Concerns

    Clinical Specialties Compounding Pharmacy is recalling Acetylcysteine 2% Solution due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Acetylcysteine 2 % Solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Devices)·Z-1655-2013·2013-07-10

    HealthLink Biopsy Punches Recalled for Lack of Sterilization

    Clorox Healthcare Holdings is recalling 1,032,700 units of PSS Select Biopsy Punches because they were not sterilized. The products were distributed nationwide and in Canada, Mexico, and New Zealand.

    Product
    PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·13V306000·2013-07-10

    Matthews Specialty Vehicles Recalls Buses Due to Awning Motor Screw Shear Risk

    Matthews Specialty Vehicles is recalling specific 2000-2013 model year buses because power awning motor assembly screws may shear, potentially causing the awning to unfurl unexpectedly.

    Product
    THOMAS BUILT — THOMAS BUILT, FREIGHTLINER, INTERNATIONAL CHSU/MICKEY, XCR, FE, TERRASTAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1646-2013·2013-07-10

    Philips CT Scanners Recalled for Image Artifacts Impairing Diagnostic Quality

    Philips is recalling Brilliance CT 64 and Ingenuity Core scanners due to software issues causing image artifacts that may impair diagnostic quality.

    Product
    Computed Tomography X-ray systems Product Usage: The Brilliance CT 64, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-671-2013·2013-07-10

    Clinical Specialties Compounding Pharmacy Recalls Test Cyp 25 mg-e(2) Blend

    Clinical Specialties Compounding Pharmacy is recalling Test Cyp 25 mg-e(2) blend 12 mg/ml due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Test Cyp 25 mg-e(2) blend 12 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Devices)·Z-1622-2013·2013-07-10

    Maquet YUNO Mobile Operating Table Recall for Extension Device Handle Issue

    Maquet is recalling YUNO mobile operating tables and extension devices because the handle design may allow operator skin to enter a gap.

    Product
    MAQUET Getinge Group Mobile Operating Table YUNO OTN GA 1433.01 EN 05. The YUNO OTN is used to support and position patients for surgical procedures immediately before, during and after the surgical phase. The table top is radio translucent and enables intraoperative use of…
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Food)·F-1591-2013·2013-07-10

    Food Concepts Recalls Big Country Breakfast Due to Salmonella Risk

    Food Concepts is recalling Big Country Breakfast because it contains texturized soy protein recalled by CHS, Inc. for possible salmonella contamination.

    Product
    BIG COUNTRY BREAKFAST, CASE WEIGHT 26 LBS., MANUFACTURED BY: FOOD CONCEPTS, LEBANON, TN 37087
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1666-2013·2013-07-10

    SpineFrontier Recalls InSpan Inserter Assemblies Due to Set Screw Deformation

    SpineFrontier, Inc. is recalling InSpan Inserter assemblies because a set screw may become deformed. The recall covers 61 units distributed worldwide.

    Product
    InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly Product Usage: Inserters are stainless steel instruments that have an inner shaft. The left and right inserters are used in combination with each other to place the implants into the body. Inserters are used to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·13V303000·2013-07-10

    Ford Recalls 2013 C-Max Hybrids for Head Injury Safety Standard Failure

    Ford is recalling 2013 C-Max hybrid vehicles without panoramic roofs because they failed to meet federal head injury safety standards. Dealers will install energy absorbers to reduce injury risk in crashes.

    Product
    FORD — FORD redundant C-MAX HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1654-2013·2013-07-10

    HealthLink Biopsy Punches Recalled for Lack of Sterilization

    Clorox Healthcare Holdings is recalling HealthLink Biopsy Punches because they were not sterilized. The recall affects 1,044,600 units distributed in the US, Canada, Mexico, and New Zealand.

    Product
    HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1618-2013·2013-07-10

    Bard StatLock CV Plus Stabilization Devices Recalled for Assembly Error

    Bard Access Systems is recalling StatLock CV Plus Stabilization Butterfly Devices due to incorrect pad assembly that may cause skin irritation or catheter mis-orientation.

    Product
    StatLock CV Plus w/Pigtail, Catheter Stabilization Device Sterile EO Single Use Only, C.R. Bard, Inc. The StatLock¿ device provides stabilization for compatible medical tubes and catheters.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1652-2013·2013-07-10

    Braemar Recalls Lithium Thionyl Battery Packs for ER920 Wireless Event Recorders

    Braemar, Inc. is recalling 3,286 non-rechargeable lithium thionyl battery packs used with ER920 Wireless Series Arrhythmia Event Recorders due to a battery-related incident.

    Product
    Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-01 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-624-2013·2013-07-10

    Baxter Recalls Sodium Chloride Injection Due to Sterility Concerns

    Baxter Healthcare is recalling specific lots of 0.9% Sodium Chloride Injection due to a manufacturing defect that may compromise sterility.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1640-2013·2013-07-10

    Surgical Instrument Service And Savings Recalls Reprocessed Medical Devices

    Surgical Instrument Service And Savings, Inc. is recalling 34 reprocessed medical devices because the sterile barrier seal became compromised, allowing product to fall out of the pouch.

    Product
    - ACCU-PASS Suture Shuttle, 70 Degree, Upbend, (Orange) Ref. 72200419 Lot 122504 - Carpal Tunnel Release Blade Assembly, (White) Ref. 81010 Lot 123263, 122406, 122482, 123043, 122518, 122511 - ENDO-SCRUB 2, (1) Sheath, 0 Degree, For K. Storz, Medtronic Sharpsite AC…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1630-2013·2013-07-10

    Surgical Instrument Service And Savings Recalls 73 Medical Devices with Compromised Sterile Seals

    Surgical Instrument Service And Savings, Inc. is recalling 73 surgical instruments and accessories because their sterile seals may be compromised, allowing product to fall out of the pouch.

    Product
    - Average Medium Blade 9mm x 25mm x 0.38mm Ref. 2296-3-111 Lot 122590, 122447 - Cannulated Drill Bit, Quick Coupling, For 3.5 & 4mm Cannulated Screws, 1.35mm Cannulation 2.7mm x 160mm Ref. 310.67 Lot 122289 - Hall MicroChoice, Oscillating Blade, Fine, Flat, Stainless…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1593-2013·2013-07-10

    Food Concepts Recalls Ragin' Cajun Due to Salmonella Risk

    Food Concepts is recalling 76 cases of Ragin' Cajun because it contains texturized soy protein recalled for possible salmonella contamination.

    Product
    RAGIN' CAJUN, WEIGHT 32 LBS, MANUFACTURED BY: FOOD CONCEPTS, LEBANON, TN 37087
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1577-2013·2013-07-10

    Cheryls Peanut Butter Cookies Recalled for Undeclared Allergen

    Cheryls is recalling Fudge Buttercream Frosted Peanut Butter cookies because some were packaged in Cinnamon Pumpkin wrappers, creating an undeclared peanut allergen risk.

    Product
    Fudge Buttercream Frosted Peanut Butter cookies, some of which were mislabeled by being wrapped in Buttercream Frosted Cinnamon Pumpkin cookie wrappers, 1.6oz (45g) in size, 1 cookie per package, 100 cookies per case.
    Category
    Food
    Distribution
    47 states
  • HighFDA (Devices)·Z-1617-2013·2013-07-10

    Biosense Webster Recalls 20-Pole LASSO Nav Catheter Eco Due to Calibration Error

    Biosense Webster is recalling 10 units of the 20-Pole LASSO Nav Catheter Eco because incorrect calibration causes the CARTO 3 System to display them as 10-Pole devices.

    Product
    20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate electrophysiological mapping of the atria of the heart.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1629-2013·2013-07-10

    Surgical Instrument Service Recalls Re-New II Endocut Scissor Tips

    Surgical Instrument Service and Savings, Inc. is recalling 10 Re-New II Endocut Scissor Tips because the sterile barrier seal is compromised, allowing the product to fall out of the pouch.

    Product
    - Re-New II Endocut Scissor Tip, 16.51mm 5.0mm Ref. 3142 Lot 122295, 122308, 122455, 122875 Manual surgical instrument for general use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1628-2013·2013-07-10

    Surgical Instrument Service Recalls Arthroscopic Electrodes Due to Seal Compromise

    Surgical Instrument Service and Savings, Inc. is recalling 447 units of arthroscopic electrodes and wands because the sterile barrier seal may be compromised, allowing product to fall out of the pouch.

    Product
    -90 Degree L-Hook Tip Arthroscopic Electrode, for use with 7205440 Switchpen, (Blue) 170mm. Ref. 7205441 Lot 122502 -Acromioplasty Electrode (Grey) 6.5" x 165mm. Ref. C5012A Lot 122288 -CAPSure 30 ArthroWand, CW, 30 Degree Shaft Angle, (Grey) 3.0mm. Ref. AC 1830-01 Lot…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1664-2013·2013-07-10

    SpineFrontier Recalls S-LIFT Instrument Cases Due to Peeling Coating

    SpineFrontier, Inc. is recalling 12 S-LIFT Instrument Cases because a bracket has a peeling nylon coating. The cases are used to hold surgical instruments for spinal fusion.

    Product
    BASE, S-LIFT Instrument Case Product Usage: System cases are designed to hold and secure all instrumentation to be used with a surgical system. Case and caddy components are used to contain implants intended for intervertebral body fusion and fixation of the spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F1582-2013·2013-07-10

    Florida Nutri Labs Recalls 4HB Stack Mealtime Due to Coating Defect

    Florida Nutri Labs is recalling 4HB Stack Mealtime caplets because they were not coated, making them difficult to swallow.

    Product
    "***DIETARY SUPPLEMENT 4HB STACK Mealtime***78 CAPLETS***MANUFACTURED EXCLUSIVELY FOR: Kirkland Science Labs 935 Jackson St #91810 Seattle, WA 98104-2818***".
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1619-2013·2013-07-10

    ConMed Linvatec Recalls Genesys Cross FT Suture Anchors Due to Incorrect Suture Color

    ConMed Linvatec is recalling 60 units of Genesys Cross FT Suture Anchors because incorrect blue/white sutures were used instead of the specified type.

    Product
    GENESYS Cross FT Suture Anchor with Two #2 (5 metric) Hi-FI Registered Trade Mark Sutures Rx Only STERILE EO CONMED LINVATEC REF CFBC-4502. Reattachment of soft tissue to bone in orthopedic surgical procedures
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1659-2013·2013-07-10

    Anspach Effort eMax 2 Plus Console Recalled for Low RPM

    The Anspach Effort, Inc. is recalling eMax 2 Plus Consoles because the motor handpiece may operate at lower speeds than specified.

    Product
    ***REF SC2102***eMax 2 Plus Console, Single Port, no Irrigation***SN G16307882402*** Product Usage: The eMax console is intended to operate the eMax system which is used for cutting and shaping bone including spine and cranium. The RPM of the Motor Handpiece may be less than…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1645-2013·2013-07-10

    Braemar Recalls Lithium Thionyl Battery Packs for ER920W Event Recorders

    Braemar Inc. is recalling 10,785 lithium thionyl battery packs used with ER920W wireless event monitors following a battery incident that caused no patient injury.

    Product
    Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-00 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F1583-2013·2013-07-10

    Florida Nutri Labs Recalls 4HB Stack Bedtime Due to Swallowing Difficulty

    Florida Nutri Labs is recalling 4HB Stack Bedtime caplets because they were not coated, making them difficult to swallow.

    Product
    "***DIETARY SUPPLEMENT 4HB STACK Bedtime***52 CAPLETS***MANUFACTURED EXCLUSIVELY FOR: Kirkland Science Labs 935 Jackson St #91810 Seattle, WA 98104-2818***".
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1639-2013·2013-07-10

    Surgical Instrument Service And Savings Recalls Relieva Flex Sinus Guide Catheter

    Surgical Instrument Service And Savings, Inc. is recalling Relieva Flex Sinus Guide Catheter and Luma Sentry 20 Tip Angle products because the sterile barrier seal may be compromised.

    Product
    - Relieva Flex Sinus Guide Catheter (Green) Tip Shape: F-70 Ref. GC070RF Lot 122429 - Relieva Luma Sentry 20 Tip Angle, 0.035 Diameter 100cm Ref. SIS100B Lot 122429 Manual surgical instrument for general use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1637-2013·2013-07-10

    TPS Micro Reciprocating Rasp Recalled Due to Compromised Sterile Seal

    Surgical Instrument Service And Savings, Inc. is recalling four units of TPS Micro Reciprocating Small Tear Cross Cut Rasps because the sterile barrier seal may be compromised.

    Product
    TPS Micro Reciprocating Small Tear Cross Cut Rasp 5.0mm x 11mm Ref. 5100-37-113 Lot 122518, 122447. Orthopedic manual surgical instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1627-2013·2013-07-10

    Surgical Instrument Service And Savings Recalls Scorpion Needles Due to Seal Compromise

    Surgical Instrument Service And Savings, Inc. is recalling specific lots of Scorpion Needles and Suture Passing Wires because the sterile barrier seal may be compromised, allowing product to fall out of the pouch.

    Product
    -Scorpion Needle, For Use With Scorpion Suture Passer, (Blue). Ref. AR-13990N Lot 123263 -SureFire Scorpion Needle (purple). Ref. AR-13991N Lot 123263 and 122279 -Suture Passing Wire. Ref. AR-1255-18 Lot 123190 Manual surgical instrument for general use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-638-2013·2013-07-10

    Diazepam 5 mg/ml Recalled for Lack of Sterility Assurance

    Clinical Specialties Compounding Pharmacy is recalling Diazepam 5 mg/ml due to FDA inspection findings regarding quality control and lack of sterility assurance.

    Product
    Diazepam 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1632-2013·2013-07-10

    Barron Radial Vacuum Trephine Set Recalled Due to Compromised Sterile Seal

    Surgical Instrument Service and Savings, Inc. is recalling Barron Radial Vacuum Trephine Sets because the sterile seal may be compromised, allowing product to fall out of the pouch.

    Product
    Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 Lot 122336 Opthalmic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1626-2013·2013-07-10

    Surgical Suture Recall Due to Compromised Sterile Barrier Seal

    Surgical Instrument Service and Savings, Inc. is recalling GII QuickAnchor Plus sutures because the sterile barrier seal may be compromised, allowing product to fall out of the pouch.

    Product
    GII QuickAnchor Plus, ETHIBOND Polyester Suture, 36", double-Armed w/CP 2 Needles 2. Ref. 212034 Lot 123266 General and Plastic Surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1642-2013·2013-07-10

    Surgical Instrument Service And Savings Recalls Phacofragmentation System Tips

    Surgical Instrument Service And Savings, Inc. is recalling specific phacofragmentation system tips because the sterile barrier seal became compromised, allowing the product to fall out of the pouch.

    Product
    - Turbosonics Mini-Flared ABS Tip, 45 Degree OZil 12 Degree, (Purplish/ Pink) 0.9mm Ref. 8065751177 Lot 123215 - TurboSonics¿ Mini-Flared ABS¿ Tip, 20 Degree Tip Angle, 45¿ Kelman, (Purplish Pink/Silver) 0.9mm Ref. 8065750853 Lot 122590, 123372 - TurboSonics¿ Tapered ABS¿…
    Category
    Medical Device
    Distribution
    Distributed nationwide

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