The Recall Desk

Archive

August 2013 recalls

504 recalls were announced in August 2013.

What the numbers show

Critical
20
Severe
126
High
185
Moderate
143
Low
30

Of the 504 recalls this month scored against our rubric, 4% are Critical, 25% are Severe.

Which agencies issued them

301–400 of 504

  • SevereFDA (Devices)·Z-1858-2013·2013-08-14

    Hospira Recalls Y-Type Blood Sets Due to Potential Bag Puncture

    Hospira Inc. is recalling 3,600 units of Y-Type Blood Sets because the piercing pin may puncture the outer wall of blood bags during insertion.

    Product
    List No. 14219-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, CLAVE Y-Site, Non-Vented, 80 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-840-2013·2013-08-14

    AstraZeneca Recalls Merrem I.V. Vials Due to Precipitate Presence

    AstraZeneca is recalling specific lots of Merrem I.V. (meropenem) because of precipitate presence, which may prevent the medication from mixing completely.

    Product
    MERREM I.V. (meropenem for injection), 1 g meropenem equivalent, 30 mL vial, Rx only, Mfd for: AstraZeneca Pharmaceuticals LP, Wilmington, DE by ACS Dobfar SpA Viale Addetta, Tribiano, Milano Italy NDC 0310 0321 30
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1856-2013·2013-08-14

    Hospira Recalls Blood Sets Due to Potential Bag Puncture Risk

    Hospira Inc. is recalling specific blood sets because the piercing pin may puncture the outer wall of blood bags during insertion.

    Product
    List No. 14212-28; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, Non-Vented, 110 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1850-2013·2013-08-14

    Hospira Recalls Secondary Blood Sets Due to Piercing Pin Defect

    Hospira Inc. is recalling 672 units of secondary blood sets because the piercing pin may puncture the outer wall of blood bags during insertion.

    Product
    List No. 14200-28; SECONDARY BLOOD SET; 200 Micron Filter, 36 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1854-2013·2013-08-14

    Hospira Recalls Blood Sets Due to Potential Puncture of Blood Bags

    Hospira Inc. is recalling 96 units of PLUM BLOOD SETS because the piercing pin may puncture the outer wall of blood bags during insertion.

    Product
    List No. 14210-28; PLUM BLOOD SET; 100 mL Burette with Prepierced Injection Site, 170 Micron Filter, Prepierced Port, Non-Vented, 105 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-852-2013·2013-08-14

    Apotex Recalls Latanoprost Ophthalmic Solution Due to Sterility Concerns

    Apotex Inc. is recalling Latanoprost Ophthalmic Solution, 0.005%, because it failed a preservative effectiveness test, raising concerns about potential microbial growth.

    Product
    Latanoprost Ophthalmic Solution, 0.005% (125 mcg/2.5 mL), 2.5 mL bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario Canada M9L 1T9; Manufactured for: Apotex Corp., Weston, FL 33326; NDC 60505-0565-1; UPC 3 60505 05651 4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1874-2013·2013-08-14

    Iradimed MRidium Dose Reduction System Recall for Infusion Rate Errors

    Iradimed is recalling MRidium 1145 Dose Reduction System kits because they may display incorrect infusion rates, posing a risk of over- or under-infusion.

    Product
    MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an option for the MRidium 3860+MR Infusion Pump System). The MRidium 3860+MRI Infusion pump are intended for general hospital or clinical use by medical professional whenever it is required to infuse…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereCPSC·13747·2013-08-14

    John Deere Recalls Compact Utility Tractors Due to ROPS Pin Failure Risk

    John Deere is recalling about 7,000 compact utility tractors because spring locking pins in the rollover protective system can break, posing a risk of serious injury or death.

    Product
    John Deere Compact Utility Tractors
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·13748·2013-08-14

    LTD Commodities Recalls Microwave Crisper Pans Due to Fire Hazard

    LTD Commodities is recalling microwave crisper pans because a metal washer can spark, posing a fire hazard. The firm reported 16 incidents involving sparks, flames, or shattered glass.

    Product
    Microwave Crisper Pan with Lids
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1853-2013·2013-08-14

    Hospira Blood Sets Recalled Due to Potential Bag Puncture Risk

    Hospira is recalling 240 blood sets because the piercing pin may puncture the outer wall of blood bags during insertion.

    Product
    List No. 14207-28; BLOOD SET; 200 Micron Filter, 105 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administration
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1887-2013·2013-08-14

    Cordis OPTEASE Retrieval IVC Filter Recall for Labeling Clarification

    Cordis Corporation is recalling 33,000 units of the OPTEASE Retrieval IVC Filter to provide additional labeling that minimizes the likelihood of implanting the filter backwards.

    Product
    Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***REF Cat. No.***466F220A and 466F220B***Vena Cava Filter and Introduction Kit***(BRITE TIP Catheter Sheath Introducer and Angiographic Vessel Dilator)***Cordis***a Johnson and Johnson Company***ENDOVASCULAR*** Label No.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1835-2013·2013-08-14

    CareFusion Recalls Alaris PC Units Due to Voltage and Communication Issues

    CareFusion is recalling Alaris PC units model 8015 because they operate at incorrect voltage and may lose communication between processors.

    Product
    Alaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic board assembly part number TC10006584. The Alaris PC Unit is the main user interface unit and power supply of the Alaris System, a modular system to be used with Alaris System modules intended for use…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-836-2013·2013-08-14

    Hospira Recalls 0.9% Sodium Chloride Injection Due to Particulate Matter

    Hospira Inc. is recalling 0.9% Sodium Chloride Injection, USP, 1000 mL containers due to the presence of small grey/brown brass particulates.

    Product
    0.9% Sodium Chloride Injection, USP, 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1922-2013·2013-08-14

    Nestle Compat Nasogastric Feeding Tubes Recalled for Sterility Concerns

    Nestle HealthCare Nutrition is recalling 37,310 Compat Nasogastric Feeding Tubes because they were delivered in insufficiently sealed pouches, compromising their sterility.

    Product
    Nestle Nutrition, Compat, Enteral Feeding Tube, sterile, 8 French (REF 08310400), 10 French (REF 08310600), and 12 French (REF 08310500). Product Usage: The Compat Nasogastric Feeding Tube is indicated for the administration of nutrition, fluids and medications into the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1931-2013·2013-08-14

    Mitsubishi VERO Linear Accelerator Software Recall for Data Storage Error

    Mitsubishi Heavy Industries is recalling VERO Linear Accelerator Systems due to a software anomaly that may save treatment records to the wrong location.

    Product
    MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earlier; Proprietary and Trade Name: MHI-TM2000/ VERO (TM); Common Name: Medical Linear Accelerator. MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1891-2013·2013-08-14

    ASO Recalls HEB Wound Closure Adhesive Surgical Tape Strips Due to Sterility Concerns

    ASO, LLC is recalling HEB Wound Closure Adhesive Surgical Tape Strips because the manufacturer cannot confirm the product's sterility.

    Product
    HEB Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 041220302536 Used to secure, close and support small cuts and wounds.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1880-2013·2013-08-14

    Stryker Recalls Sonopet Ultrasonic Aspirator Consoles Due to Corrosion

    Stryker is recalling 215 Sonopet Ultrasonic Aspirator Consoles because corrosion on a power supply component may cause the irrigation pump to stop working.

    Product
    Sonopet Ultrasonic Aspirator Console 5450-852-000 (Console 230V) Product Usage: The Sonopet Console is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft and hard tissue is desirable, including neurosurgery, gastrointestinal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1886-2013·2013-08-14

    Siemens IMMULITE Rapid TSH Recalled for Rare TSH Variant Detection Failure

    Siemens Healthcare Diagnostics is recalling IMMULITE Systems Rapid TSH tests because they fail to detect a rare TSH variant identified in a small patient cluster.

    Product
    IMMULITE Systems Rapid TSH (REF LKRT1 - 100T, LKRT5 - 500 T, L2KRT2 - 200T, L2KRT6 - 600T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1890-2013·2013-08-14

    ASO Recalls Duane Reade Wound Closure Adhesive Surgical Tape Strips

    ASO, LLC is recalling Duane Reade Wound Closure Adhesive Surgical Tape Strips because the manufacturer cannot confirm the products are sterile.

    Product
    Duane Reade (DR) Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 639194043885 Used to secure, close and support small cuts and wounds.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1885-2013·2013-08-14

    Siemens IMMULITE TSH Assay Recalled for Rare Variant Detection Failure

    Siemens Healthcare Diagnostics is recalling IMMULITE Systems Third Generation TSH assays because a rare TSH variant is not detected.

    Product
    IMMULITE Systems Third Generation TSH (REF LKTS1 - 100T, LKTS5 - 500T, L2KTS2 - 200T, L2KTS6 - 600T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1928-2013·2013-08-14

    Smith & Nephew Recalls R3 XLPE Acetabular Liners Due to Packaging Error

    Smith & Nephew is recalling 53 units of R3 XLPE acetabular liners because some 60 mm and 62 mm liners may be laser etched and packaged with incorrect size labels.

    Product
    R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 62 MM OD, QTY: (1), STERILE H2O2, REF 71335762. Orthopaedic.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Food)·F-1790-2013·2013-08-14

    Giant Eagle Chocolate Covered Peanuts Recalled for Undeclared Milk Allergen

    Giant Eagle is recalling Chocolate Covered Peanuts because the label fails to clearly state the presence of a milk allergen, listing only whey.

    Product
    Giant Eagle Candy Place Chocolate Covered Peanuts NET WT. 5 OZ, UPC code 3003404313 This product was packaged in a facility that also processes peanuts, nuts, milk products, soy, wheat, sesame seeds, whey and eggs. Distributed By: Giant Eagle, Inc. Pittsburgh, PA…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1926-2013·2013-08-14

    SpineFrontier Recalls Rev E PedFuse Return Screw Inserters Due to Loose Set Screw

    SpineFrontier, Inc. is recalling eight Rev E PedFuse Return Screw Inserters because a set screw can loosen, causing the collar and locking sleeve to slide off the instrument.

    Product
    Rev E PedFuse Return Screw Inserter, Part Number: 11-80030 Screw inserters are instruments which capture, hold and drive pedicle screw assemblies. There is a capturing feature that engages and holds the screw in place. There is also a feature used to lock the screw to the…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-1786-2013·2013-08-14

    Aqua Star Raw Shrimp Recalled Due to Salmonella Contamination

    Aqua Star (USA) Corp. is recalling raw frozen shrimp due to Salmonella. Consumers in NJ, MA, PA, and NY should discard the product.

    Product
    The master case Bar Code is 20731149654062 and the Retail UPC is 7 31149 65406 8. The Retail Label reads in part "*** Aqua Star Raw Shrimp Easy-Peel Shell-On*** Ready to Cook *** Net Wt 1 lb (454g) ***"
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-1789-2013·2013-08-14

    Olam Tomato Processors Recalls Medium Chunky Salsa Due to Glass Fragments

    Olam Tomato Processors is recalling 12,870 cases of Home Style Select Medium Chunky Salsa because consumers reported finding large fragments of glass inside the jars.

    Product
    Medium Chunky Salsa, a Home Style Select brand, in 16oz glass jars, UPC: 3927759139; Product is distributed by Dollar Tree; Product is processed and packaged by Olam Tomato Processors, Inc. Lemoore, CA; The label on the salsa indicates distributed by Greenbrier International…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1894-2013·2013-08-14

    ASO Recalls Premier Value Wound Closure Adhesive Tape Due to Sterility Concerns

    ASO, LLC is recalling Premier Value Wound Closure Adhesive Surgical Tape Strips because the manufacturer could not confirm the product's sterility.

    Product
    Premier Value Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 040986021558 Used to secure, close and support small cuts and wounds.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1896-2013·2013-08-14

    ASO Recalls Walgreens Wound Closure Adhesive Surgical Tape Strips

    ASO, LLC is recalling specific lots of Walgreens wound closure adhesive surgical tape strips because the manufacturer could not confirm the products were sterile.

    Product
    Walgreens ("W" and "Well at Walgreens") Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # ("W") 311917111728 item # 479241 UPC # ("Well at Walgreens") 311917143354 item # 156744 Used to secure, close and support small cuts…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1878-2013·2013-08-14

    Stryker Sonopet Ultrasonic Aspirator Console Recall for Corrosion Defect

    Stryker is recalling 215 Sonopet Ultrasonic Aspirator Consoles because corrosion on a power supply component may cause the irrigation pump to stop working during surgery.

    Product
    Sonopet Ultrasonic Aspirator Console (Console 110V with Pedal & Pole) Product Usage: The Sonopet Console is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft and hard tissue is desirable, including neurosurgery…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1879-2013·2013-08-14

    Stryker Sonopet Ultrasonic Aspirator Console Recalled for Corrosion

    Stryker is recalling 215 Sonopet Ultrasonic Aspirator Consoles because corrosion on a power supply component may cause the irrigation pump to stop working.

    Product
    Sonopet Ultrasonic Aspirator Console 5450-851-000(Console 100V) Product Usage: The Sonopet Console is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft and hard tissue is desirable, including neurosurgery…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0833-2013·2013-08-14

    Ventana BenchMark ULTRA Staining Platform Recalled for Fluid Overflow Risk

    Ventana Medical Systems is recalling 1,735 BenchMark ULTRA automated staining platforms due to a potential waste fluid overflow that could cause electrical shorting.

    Product
    VENTANA (a member of the Roche Group) BenchMark ULTRA; REF/MU 750-600; Research Use Only Product Usage: Research Use Only-The DISCOVERY ULTRA Advanced Staining System is intended to automatically stain histological or cytological specimens on microscope slides with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1788-2013·2013-08-14

    Olam Tomato Processors Recalls Mild Chunky Salsa Due to Glass Fragments

    Olam Tomato Processors is recalling Mild Chunky Salsa sold at Dollar Tree stores because consumers reported finding large fragments of glass inside the jars.

    Product
    Mild Chunky Salsa, a Home Style Select brand, in 16oz glass jars, UPC: 3927759137; Product is distributed by Dollar Tree; Product is processed and packaged by Olam Tomato Processors, Inc. Lemoore, CA; The label on the salsa indicates distributed by Greenbrier International…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1932-2013·2013-08-14

    SpineFrontier T-Handle Strike Plate Separation Recall

    SpineFrontier, Inc. is recalling 11 T-Handles because the strike plate loosened and separated during an operation.

    Product
    T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A T-handles are silicone handled instruments that have a quick release end. The silicone T-handle has an impactor cap on the proximal end of the handle which is designed to be struck with a mallet. T-handles…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1924-2013·2013-08-14

    Siemens Recalls Dimension Tacrolimus Flex Reagent Cartridges Due to Low Recovery

    Siemens Healthcare Diagnostics is recalling specific lots of Dimension Tacrolimus Flex reagent cartridges and calibrators because they may produce falsely low test results, potentially affecting medication dosing for transplant patients.

    Product
    Dimension Tacrolimus Flex reagent cartridge (DF107) and Dimension TACR CAL (DC107) Product Usage: The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension clinical chemistry system. Measurements of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1883-2013·2013-08-14

    Siemens Dimension EXL TSH Reagent Cartridge Recall for Rare Variant Detection

    Siemens Healthcare Diagnostics is recalling Dimension EXL TSH reagent cartridges because they fail to detect a rare TSH variant found in a small patient cluster.

    Product
    Dimension EXL LOCI Module TSHL Flex Reagent Cartridge (REF RF612). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·13V362000·2013-08-14

    Ice Castle RV Edition Recalled for Awning Motor Screw Shear Risk

    American Surplus is recalling 2014 Ice Castle RV Edition vehicles because awning motor screws may shear, causing the awning to unfurl unexpectedly and increasing injury or crash risk.

    Product
    ICE CASTLE — ICE CASTLE RV EDITION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1881-2013·2013-08-14

    Siemens ADVIA Centaur TSH3 Ultra ReadyPack Recalled for Rare TSH Variant Detection Failure

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Systems TSH3 Ultra ReadyPacks because a rare variant of TSH is not detected by the test.

    Product
    ADVIA Centaur Systems TSH3 Ultra ReadyPack ((REF 06491072 - 100 Tests, REF 06491080 - 500 Tests, REF 04862625 - 2500T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1892-2013·2013-08-14

    ASO Leader Wound Closure Adhesive Surgical Tape Strips Recalled for Sterility Concerns

    ASO, LLC is recalling Leader Wound Closure Adhesive Surgical Tape Strips because the company cannot confirm the products are sterile.

    Product
    Leader Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 096295114706 Used to secure, close and support small cuts and wounds.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1893-2013·2013-08-14

    Meijer Wound Closure Adhesive Surgical Tape Strips Recalled for Sterility Concerns

    ASO, LLC is recalling Meijer Wound Closure Adhesive Surgical Tape Strips because the manufacturer could not confirm the product's sterility.

    Product
    Meijer Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 719283595973 Used to secure, close and support small cuts and wounds.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·13V361000·2013-08-14

    Recreation by Design Recalls 2013 Travel Trailers Due to Awning Motor Defect

    Recreation by Design is recalling 2013 Monte Carlo, Royal Travel, and North American travel trailers because a damaged awning motor may cause the awning to unfurl unexpectedly, increasing injury or crash risk.

    Product
    MONTE CARLO — MONTE CARLO, ROYAL TRAVEL, NORTH AMERICAN 44 SC FW, 44 SC, 39 SC, 35 SC FW
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1923-2013·2013-08-14

    BD Vacutainer Luer Adapter Recalled for Potential Blood Leakage and Low Draw Volume

    Becton Dickinson is recalling BD Vacutainer Multiple Sample and Direct Draw Luer Adapters due to potential blood leakage and low draw volume.

    Product
    BD Vacutainer Multiple Sample and Direct Draw Luer Adapter BD Franklin Lakes, NJ 07417 USA A sterile non-invasive device used to connect venous access devices such as needles, blood collection sets, ad infusion sets to blood collection tubes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1895-2013·2013-08-14

    TopCare Wound Closure Adhesive Surgical Tape Strips Recalled for Sterility Concerns

    ASO, LLC is recalling TopCare Wound Closure Adhesive Surgical Tape Strips because the manufacturer cannot confirm the product's sterility.

    Product
    TopCare Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 036800165854 Used to secure, close and support small cuts and wounds.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0834-2013·2013-08-14

    Ventana Discovery Ultra Staining Systems Recalled for Waste Fluid Overflow Risk

    Ventana Medical Systems is recalling 54 Discovery Ultra automated staining systems because waste fluid drainage may become restricted, leading to overflow and potential fluid migration.

    Product
    VENTANA (a member of the Roche Group) DISCOVERY ULTRA; REF/MU 750-601; Research Use Only Product Usage: Research Use Only-The DISCOVERY ULTRA Advanced Staining System is intended to automatically stain histological or cytological specimens on microscope slides with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1889-2013·2013-08-14

    ASO Recalls Wound Closure Tape Strips Due to Sterility Concerns

    ASO, LLC is recalling Discount Drug Mart wound closure adhesive tape strips because the company cannot confirm the product is sterile.

    Product
    Discount Drug Mart Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 093351120374 Used to secure, close and support small cuts and wounds.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1888-2013·2013-08-14

    CVS Pharmacy Wound Closure Adhesive Surgical Tape Strips Recalled for Sterility Concerns

    ASO, LLC is recalling CVS Pharmacy Wound Closure Adhesive Surgical Tape Strips because the manufacturer cannot confirm the product's sterility.

    Product
    CVS Pharmacy Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 050428102909 item # 409170 Used to secure, close and support small cuts and wounds.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1930-2013·2013-08-14

    Radiometer TCM4 Base Units Recalled for Electrical Safety Non-Compliance

    Radiometer America Inc is recalling TCM4 series Base Units and Power Supplies because they do not comply with IEC 60601-1 Sub Clause 15B electrical safety standards.

    Product
    TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej 21, Br¿nsh¿j, Denmark, www.radiometer.com. The devices are intended for continuous monitoring of carbon dioxide and oxygen partial pressures, oxygen saturation, and pulse rate.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1871-2013·2013-08-14

    SpineFrontier Recalls Chameleon FacetFuse Drill Guides Due to Mechanical Interference

    SpineFrontier, Inc. is recalling 13 Chameleon FacetFuse Drill Guides because denting and bending prevented proper surgical use.

    Product
    Drill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev. A FacetFuse Drill Guides were designed to provide a concentric pathway for the drills and taps to access the bone while protecting the soft tissue from the cutting geometry of the drills/taps. In addition…
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-848-2013·2013-08-14

    Teva Recalls Methylphenidate Hydrochloride Capsules Due to Dissolution Failures

    Teva Pharmaceuticals is recalling 13,478 bottles of Methylphenidate Hydrochloride Extended-Release Capsules because routine stability testing revealed out-of-specification dissolution results.

    Product
    METHYLPHENIDATE HYDROCHLORIDE — METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1911-2013·2013-08-14

    BioMerieux Vitek 2 Software Recall for Antibiotic Code Errors

    BioMerieux is recalling Vitek 2 software version 6.01 because specific antibiotic codes are not updated correctly when interfaced with Laboratory Information Systems.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 EN. Part number: 414560. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1913-2013·2013-08-14

    BioMérieux Vitek 2 Software Version 6.01 Recalled for Interface Error

    BioMérieux is recalling Vitek 2 software version 6.01 because antibiotic codes for three specific drugs are not updated correctly when interfaced with Laboratory Information Systems.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 FR. Part number: 414562. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1872-2013·2013-08-14

    Precision Dynamics Recalls Non-Sterile Viscot Surgical Skin Markers

    Precision Dynamics Corporation is recalling 1,200 non-sterile Viscot surgical skin markers because they were mislabeled as sterile.

    Product
    Non-sterile Viscot Surgical Skin Markers Part Number 1437-100 Non-sterile Viscot Part Number 143-100 Surgical Skin Markers are pen-like devices intended to be used to write on the patient's skin, e.g., to outline surgical incision sites or mark anatomical sites for…
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-851-2013·2013-08-14

    Hospira Recalls Ondansetron Injection Due to Particulate Matter

    Hospira is recalling 340,600 vials of Ondansetron Injection due to the discovery of particulate matter in a preceding lot.

    Product
    ONDANSETRON — ONDANSETRON (ONDANSETRON)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1914-2013·2013-08-14

    Biomerieux Vitek 2 Software Version 6.01 Recalled for Interface Errors

    Biomerieux Inc. is recalling Vitek 2 Systems Software version 6.01 because specific antibiotic codes are not updated properly when interfaced with a Laboratory Information System.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 IT. Part number: 414563. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1916-2013·2013-08-14

    BioMerieux Vitek 2 Software Version 6.01 Recalled for Interface Errors

    BioMerieux is recalling Vitek 2 software version 6.01 because antibiotic codes for Cefovecin, Prulifloxacin, and Ceftaroline are not updated properly when interfaced with Laboratory Information Systems.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 NO. Part number: 414565. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1927-2013·2013-08-14

    SpineFrontier Recalls Invue Split Driver Devices Due to Design Flaw

    SpineFrontier, Inc. is voluntarily recalling 12 Invue Split Driver devices due to a device design issue. The recall covers units distributed nationwide.

    Product
    Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 501(k) clearance number K121060. The Invue Driver is an instrument consisting of a Radel handle, a shaft and hexalobe-like tip with a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1925-2013·2013-08-14

    Siemens Mass Creatine Kinase MB Isozyme Calibrator Recalled for Dissolution Issues

    Siemens Healthcare Diagnostics is recalling 7,470 units of the Dimension Mass Creatine Kinase MB Isozyme Calibrator because the lyophilized cake may not fully dissolve.

    Product
    Dimension(R) Mass Creatine Kinase MB Isozyme Calibrator (RC420) The Mass Creatine Kinase MB isozyme Calibrator is an in vitro diagnostic product intended to be used to calibrate the Creatine Kinase MB Isozyme method for the Dimension(R) clinical chemistry system with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-847-2013·2013-08-14

    Teva Recalls Methylphenidate Hydrochloride Capsules for Dissolution Failures

    Teva Pharmaceuticals is recalling 16,293 bottles of Methylphenidate Hydrochloride Extended-Release Capsules because routine stability testing revealed out-of-specification dissolution results.

    Product
    METHYLPHENIDATE HYDROCHLORIDE — METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1933-2013·2013-08-14

    SpineFrontier Recalls Indus Invue Screw Caddies Due to Removal Difficulty

    SpineFrontier, Inc. is recalling Indus Invue Screw Caddies because screws are difficult to remove from the device. The recall affects 13 units distributed in the US and Jamaica.

    Product
    Indus Invue Screw Caddy, Model: SI70097 The caddy holds, in an organized fashion within the case, a variety of shapes and sizes of plates and screws used during fixation of anterior cervical plates to provide stabilization during the development of spine fusions. There is an…
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1907-2013·2013-08-14

    BioMérieux Vitek 2 Software Version 6.01 Recalled for Interface Errors

    BioMérieux is recalling Vitek 2 Systems Software version 6.01 because antibiotic codes for three specific drugs are not updated properly when interfaced with Laboratory Information Systems.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, V2S 6.01 RP5800-WES7 Media. Part number: 413861. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1920-2013·2013-08-14

    BioMerieux Vitek 2 Software Version 6.01 Recalled for Interface Errors

    BioMerieux Inc is recalling Vitek 2 Systems Software version 6.01 because antibiotic codes for three specific drugs are not updated correctly when interfacing with Laboratory Information Systems.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 ZH. Part number: 414569. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1921-2013·2013-08-14

    BioMérieux Vitek 2 Software Version 6.01 Recalled for Interface Errors

    BioMérieux is recalling Vitek 2 software version 6.01 because antibiotic codes for three specific drugs are not updated properly when interfaced with Laboratory Information Systems.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit V2S RP5800XPE TO 6.01 WES7. Part number: 6201773. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1915-2013·2013-08-14

    BioMérieux Vitek 2 Software Recall Due to Antibiotic Code Errors

    BioMérieux is recalling Vitek 2 software version 6.01 because antibiotic codes for three drugs are not updated correctly when interfaced with laboratory systems.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 JA. Part number: 414564. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1919-2013·2013-08-14

    BioMerieux Vitek 2 Software Recall for Antibiotic Code Errors

    BioMerieux is recalling Vitek 2 Systems Software version 6.01 because antibiotic codes for three specific drugs were not updated correctly during a software upgrade.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 EL, TR. Part number: 414568. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1929-2013·2013-08-14

    Smith & Nephew Recalls R3 XLPE Acetabular Liners Due to Mislabeling

    Smith & Nephew is recalling specific batches of R3 XLPE acetabular liners because some 60 mm and 62 mm units may be mislabeled with incorrect size markings.

    Product
    R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 60 MM OD, QTY: (1), STERILE H2O2, REF 71335760. Orthopaedic.
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-1882-2013·2013-08-14

    Siemens Dimension TSH Flex Reagent Cartridge Recall for Rare Variant Detection Failure

    Siemens Healthcare Diagnostics is recalling Dimension TSH Flex Reagent Cartridges because a rare variant of TSH is not detected.

    Product
    Dimension TSH Flex Reagent Cartridge (REF RF412). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-846-2013·2013-08-14

    Novartis Recalls Parsel Plus Pouches Due to Potential Sealing Defects

    Novartis is recalling 472,000 pouches of Parsel Plus in Brazil and Panama because the packaging may not be fully sealed.

    Product
    Parsel Plus (reference US product: Excedrin Tension Headache) (Acetaminophen 500 mg and Caffeine 65 mg), packaged in 2-count pouches, Distributed by Novartis Consumer Health, Inc., USA and Novartis Consumer Health S.A., Brazil, for Novartis de Venezuela. The foreign…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1908-2013·2013-08-14

    BioMerieux Vitek 2 Software Recall for Interface Code Errors

    BioMerieux is recalling Vitek 2 software version 6.01 because antibiotic codes for three specific drugs were not updated correctly during the software upgrade.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01ML1. Part number: 414537. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-854-2013·2013-08-14

    Sandoz Recalls Introvale Contraceptive Tablets Due to Sequence Error

    Sandoz is voluntarily recalling Introvale contraceptive tablets because inactive and active pills were placed in the wrong weeks on the blister card.

    Product
    Introvale (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 mg, packaged in 91 day regimen per unit carton, 3 Unit Cartons x 91 tablets per box, Rx only, Manufactured by Laboratorios Leon Farma S.A., Spain for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5584-36
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1876-2013·2013-08-14

    Medtronic Mullins Transseptal Catheter Sheath Recall for Labeling Error

    Medtronic is recalling specific lots of Mullins Transseptal Catheter Introducer Sheaths because packages labeled as 7F may contain 8F dilators.

    Product
    Medtronic Mullins Transseptal Adult 7F, REF 008551. Intended for the introduction of cardiovascular catheters into the left side of the heart.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-849-2013·2013-08-14

    Teva Recalls Methylphenidate Hydrochloride Extended-Release Capsules Due to Dissolution Failure

    Teva Pharmaceuticals is recalling 7,579 bottles of Methylphenidate Hydrochloride Extended-Release Capsules because routine stability testing revealed out-of-specification dissolution results.

    Product
    METHYLPHENIDATE HYDROCHLORIDE — METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-842-2013·2013-08-14

    Teva Recalls Terazosin Hydrochloride Capsules Due to Labeling Error

    Teva Pharmaceuticals is recalling 6,267 bottles of Terazosin Hydrochloride capsules because the 10 mg label contained 5 mg capsules.

    Product
    Terazosin Hydrochloride Capsules,10 mg, 100-count bottle, Rx only, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-4339-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1917-2013·2013-08-14

    BioMérieux Vitek 2 Software Recall for Antibiotic Code Errors

    BioMérieux is recalling Vitek 2 software version 6.01 because specific antibiotic codes are not updated correctly when interfaced with Laboratory Information Systems.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 PT. Part number: 414566. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-844-2013·2013-08-14

    Novartis Recalls Excedrin Migraine Pouches Due to Incomplete Seals

    Novartis is recalling 10.6 million Excedrin Migraine pouches because the packaging may not be fully sealed, potentially compromising product integrity.

    Product
    Excedrin Migraine (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-count tablets packaged in pouches, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 203 702 Foreign packaging: b) Excedrin Migrana (Acetaminophen 250 mg, Aspirin…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1909-2013·2013-08-14

    BioMerieux Vitek 2 Software Recall for Antibiotic Code Errors

    BioMerieux is recalling Vitek 2 software version 6.01 because specific antibiotic codes were not updated correctly during an upgrade, potentially affecting laboratory reporting.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01ML2. Part number: 414538. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-843-2013·2013-08-14

    Novartis Recalls Excedrin Extra Strength Due to Unsealed Pouches

    Novartis is recalling Excedrin Extra Strength tablets in pouches that may not be fully sealed. The recall covers products distributed in the US, Puerto Rico, Brazil, and Panama.

    Product
    Excedrin Extra Strength (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-ct tablets in pouches b) boxes of 50/2-ct packages, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 2030 02 Foreign packaging: c) Parsel Forte and d)…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-853-2013·2013-08-14

    West-Ward Recalls Lisinopril Tablets Due to Impurity Test Failures

    West-Ward Pharmaceutical Corp. is recalling 51,704 bottles of Lisinopril Tablets, USP, 2.5 mg because they failed impurity specifications at the 48-month time point.

    Product
    Lisinopril Tablets, USP, 2.5 mg, Rx only, packaged in a) 100-count bottles (NDC 0143-1265-01) and b) 1000-count bottles (NDC 0143-1265-10), Manufactured by: West-ward Pharmaceutical Corp., Eatontown, N.J. 07724; and c) 1000-count bottles (NDC 24658-240-10), Manufactured for: Blu…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1910-2013·2013-08-14

    BioMerieux Vitek 2 Software Version 6.01 Recalled for Interface Errors

    BioMerieux is recalling Vitek 2 software version 6.01 because specific antibiotic codes are not updated properly when interfaced with Laboratory Information Systems.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 DE. Part number: 414539. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-856-2013·2013-08-14

    Zolpidem Tartrate Tablets Recalled for Potential Unit Dose Mispackaging

    American Health Packaging is recalling Zolpidem Tartrate 5 mg tablets due to a packaging error that may result in blisters containing more than one tablet.

    Product
    Zolpidem Tartrate Tablets 5 mg, 10 tablets per blister, 10 blisters per carton, 100 cartons per box, Rx Only, Manufactured for Wockhardt USA LLC., Parsippany, NJ 07054 by Wockhardt Limited, Mumbai, India, NDC 68084-225-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1918-2013·2013-08-14

    BioMérieux Vitek 2 Software Recall for Antibiotic Code Errors

    BioMérieux is recalling Vitek 2 Systems Software version 6.01 because specific antibiotic codes are not updated properly when interfaced with Laboratory Information Systems.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 DA, SV. Part number: 414567. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1912-2013·2013-08-14

    BioMerieux Vitek 2 Software Recall for Antibiotic Code Errors

    BioMerieux is recalling Vitek 2 software version 6.01 because antibiotic codes for three specific drugs are not updated properly when interfaced with Laboratory Information Systems.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 ES. Part number: 414561. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1884-2013·2013-08-14

    Siemens TSH Reagent Cartridge Recall for Rare Variant Detection Failure

    Siemens Healthcare Diagnostics is recalling Dimension Vista System TSH Flex Reagent Cartridges because a rare variant of TSH is not detected.

    Product
    Dimension Vista System TSH Flex Reagent Cartridge (REF K6412). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-839-2013·2013-08-14

    West-Ward Recalls Ethambutol Hydrochloride Tablets Due to Surface Ink Defects

    West-Ward Pharmaceutical Corp. is recalling 118 bottles of Ethambutol Hydrochloride Tablets 400 mg due to out-of-specification surface ink defects.

    Product
    VersaPharm Incorporated, Ethambutol Hydrochloride Tablets, USP 400 mg 60 tablets, Rx Only, Mfd. for VersaPharm Incorporated Marietta, GA 30065-1509; Mfd. by: West-ward Pharmaceuticals Corp., Eatontown, NJ 07724 NDC 61748-014-06,
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-855-2013·2013-08-14

    Actavis Recalls BuPROPion Hydrochloride Extended-Release Tablets for Dissolution Failure

    Actavis Inc is recalling 15,132 bottles of BuPROPion Hydrochloride Extended-Release Tablets (XL) 300 mg because dissolution test results exceeded approved limits.

    Product
    BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic, LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217, NDC 67767-142-30, UPC 3 67767-142-30 6.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1873-2013·2013-08-14

    Beckman Coulter AU5800 Clinical Chemistry Analyzer Recall for Labeling Defect

    Beckman Coulter is recalling AU5800 Clinical Chemistry Analyzers because the diluted detergent tank lacks labeling for the on/off valve disposition.

    Product
    Beckman Coulter AU5800 Clinical Chemistry Analyzer, All Serial Numbers. An automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC), material and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-845-2013·2013-08-14

    Novartis Recalls No Doz Max Strength Caffeine Caplets Due to Packaging Defect

    Novartis Consumer Health is recalling No Doz Max Strength caplets because the pouches may not be fully sealed.

    Product
    No Doz, Max Strength (200 mg caffeine) caplets, 2-count caplets per pouch, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 2070 02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V356000·2013-08-13

    Kia Recalls 2014 Sorento Vehicles Due to Front Axle Shaft Fracture Risk

    Kia is recalling specific 2014 Sorento vehicles because a manufacturing issue may cause the right front axle shaft to fracture, potentially leading to loss of power or the vehicle rolling away.

    Product
    KIA — KIA SORENTO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V359000·2013-08-13

    Pierce Recalls One 2008 Oshkosh Trailer Due to Fire Risk

    Pierce Manufacturing is recalling one 2008 Oshkosh AMAMTH-2 trailer because a wheelchair lift cable may cause a short circuit and fire.

    Product
    OSHKOSH — OSHKOSH AMAMTH-2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V349000·2013-08-13

    Volvo Trucks Recall 2011-2012 Models for Wiper Motor Failure

    Volvo Trucks North America is recalling 2011-2012 VAH, VHD, VNL, and VNM trucks because the windshield wiper motor may fail, increasing crash risk.

    Product
    VOLVO — VOLVO VAH, VNM, VHD, VNL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13263·2013-08-13

    Husqvarna Recalls 2013 Off-Road Motorcycles Due to Throttle Cable Crash Hazard

    Husqvarna is recalling about 260 2013 closed-course and competition off-road motorcycles because a malfunctioning throttle cable can cause the rider to lose speed control, posing a crash hazard.

    Product
    Husqvarna closed course/competition off-road motorcycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V354000·2013-08-12

    Hyundai Recalls Sonata and Azera for Rear Suspension Corrosion Risk

    Hyundai is recalling 2006-2011 Sonata and Azera vehicles in 22 states and D.C. because road salt can corrode the rear crossmember, potentially causing a control arm to detach.

    Product
    HYUNDAI — HYUNDAI AZERA, SONATA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V353000·2013-08-12

    Spartan Aerial Fire Vehicles Recalled for Detaching Rotation Interlock Magnets

    Spartan ERV is recalling specific aerial fire vehicles because adhesive on rotation interlock magnets degrades, causing them to detach and potentially leading to vehicle instability and rollover.

    Product
    SPARTAN — SPARTAN RMA 103, RMP 100, RMA 75, TDA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13E043000·2013-08-12

    Airtex Fuel Pumps Recalled for Potential Fire Risk in GM Vehicles

    Airtex is recalling fuel pumps for certain 2004-2008 GM vehicles because an electrical connector may not seal, allowing fuel to escape and increasing fire risk.

    Product
    EQUIPMENT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V366000·2013-08-09

    Volvo Recalls 2013-2014 VNL Trucks Due to Driveshaft Failure Risk

    Volvo Trucks North America is recalling 2013-2014 VNL trucks because a weak driveshaft may fail, potentially causing debris on the roadway and increasing crash risk.

    Product
    VOLVO — VOLVO VNL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·13260·2013-08-08

    Big Lots Recalls Citronella Tabletop Torches Due to Fire and Burn Hazards

    Big Lots is recalling approximately 30,000 citronella tabletop torches sold nationwide from March to June 2013 because they can flare up and emit burning fuel, posing fire and burn risks.

    Product
    Citronella Tabletop Torches
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·13V350000·2013-08-08

    OBS Recalls Four Motorhomes Due to Power Awning Motor Defect

    OBS is recalling four motorhomes because a design change in the power awning motor assembly may cause screws to shear, potentially allowing the awning to unfurl unexpectedly.

    Product
    ROYAL — ROYAL, OBS RTBGN, ADVENTURE III, CONCEPT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V357000·2013-08-08

    Outdoors RV Recalls 2013-2014 Trailers Due to Awning Motor Defect

    Outdoors RV is recalling specific 2013-2014 Creek Side, Timber Ridge, Wind River, and Black Stone trailers because the power awning motor screws may shear, causing the awning to unfurl unexpectedly.

    Product
    CREEK SIDE — CREEK SIDE, TIMBER RIDGE, WIND RIVER 23RKS, 23BHS, 22RB, 18CK
    Category
    Vehicle
    Distribution
    Distributed nationwide

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