The Recall Desk

Archive

January 2014 recalls

1,423 recalls were announced in January 2014.

What the numbers show

Critical
161
Severe
415
High
291
Moderate
533
Low
23

Of the 1,423 recalls this month scored against our rubric, 11% are Critical, 29% are Severe.

801–900 of 1423

  • ModerateFDA (Drugs)·D-725-2014·2014-01-22

    Ramipril Capsules Recalled for Potential Label Mixup with Other Medications

    Aidapak Services is recalling Ramipril 2.5 mg capsules because they may be mislabeled as Propafenone HCl or Calcium Polycarbophil.

    Product
    RAMIPRIL, Capsule, 2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68180058901
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0752-2014·2014-01-22

    Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors

    The Anspach Effort, Inc. is recalling all lots of MCA Cutting Burrs and Dissection Tools because the indications for use were broader than validated and directions were unclear.

    Product
    MCA5-07SD - 0.7MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-692-2014·2014-01-22

    Lisinopril Tablets Recalled for Potential Labeling Errors

    Aidapak Services is recalling Lisinopril 2.5 mg tablets because they may be mislabeled as Ranolazine ER or Docusate Sodium.

    Product
    LISINOPRIL Tablet, 2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64679092701
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-549-2014·2014-01-22

    FDA Recalls Coenzyme Q-10 Capsules Due to Potential Labeling Errors

    Aidapak Services is recalling Coenzyme Q-10 capsules because they may be mislabeled as other prescription or over-the-counter medications.

    Product
    COENZYME Q-10, Capsule 100 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 37205055065
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-730-2014·2014-01-22

    Verapamil HCL ER Tablets Recalled for Potential Labeling Mixup

    Aidapak Services, LLC is recalling Verapamil HCL ER 240 mg tablets because they may be mislabeled as Trifluoperazine HCL 1 mg.

    Product
    VERAPAMIL HCL ER, Tablet, 240 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68462026001
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-488-2014·2014-01-22

    Aidapak Recalls Cholecalciferol Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling 2,998 tablets of Cholecalciferol 2000 units because they may be mislabeled as other medications.

    Product
    CHOLECALCIFEROL, Tablet, 2000 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904615760
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-724-2014·2014-01-22

    Aidapak Recalls Quinapril HCL Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling 20 mg Quinapril HCL tablets because they may be mislabeled as Multivitamin/Multimineral tablets.

    Product
    QUINAPRIL HCL, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68180055809
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-528-2014·2014-01-22

    Aidapak Recalls Metformin HCl Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling metFORMIN HCl 500 mg tablets because they may be mislabeled as Omega-3 Fatty Acid capsules.

    Product
    metFORMIN HCl Tablet 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23155010201
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-534-2014·2014-01-22

    Venlafaxine HCL Tablets Recalled for Potential Labeling Error

    Aidapak Services is recalling Venlafaxine HCL 50 mg tablets because they may be mislabeled as sulfasalazine 500 mg.

    Product
    VENLAFAXINE HCL Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23155024801
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-656-2014·2014-01-22

    Sennosides Tablets Recalled for Potential Labeling Mixup with Saccharomyces Boulardii

    Aidapak Services, LLC is recalling Sennosides Tablets due to a potential labeling mixup with Saccharomyces Boulardii capsules. The error involves incorrect product identification on the label.

    Product
    SENNOSIDES Tablet, 8.6 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 60258095001
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0717-2014·2014-01-22

    Leica Biosystems Recalls BOND Polymer Refine Red Detection Due to Fungal Contamination

    Leica Biosystems is recalling BOND Polymer Refine Red Detection kits because they may contain fungal contaminants that can cause staining sensitivity loss or fluid delivery obstructions.

    Product
    Leica BIOSYSTEMS; BOND Polymer Refine Red Detection; Catalog No: DS9390; Leica Biosystems Newcastle Ltd; Balliol Business Park West; Benton Lane; Newcastle Upon Tyne NE12 8EW; United Kingdom; www.LeicaBiosystems.com; Bond Polymer Refine Red Detection is a biotin-free, polymeric a
    Category
    Medical Device
    Distribution
    40 states
  • ModerateFDA (Drugs)·D-690-2014·2014-01-22

    Aidapak Recalls 40 mg Pantoprazole Sodium Tablets Due to Labeling Mixup

    Aidapak Services, LLC is recalling 1,001 tablets of 40 mg Pantoprazole Sodium due to a potential labeling mixup with Sennosides.

    Product
    PANTOPRAZOLE SODIUM DR Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64679043402
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-601-2014·2014-01-22

    Etodolac Tablets Recalled for Potential Labeling Error

    Aidapak Services is recalling Etodolac 400 mg tablets due to a potential label mixup with Pancrelipase DR capsules.

    Product
    ETODOLAC Tablet, 400 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 51672401801
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-467-2014·2014-01-22

    Aidapak Recalls Niacin TR Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Niacin TR tablets because they may be mislabeled as Lactobacillus GG capsules.

    Product
    NIACIN TR, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00904434260
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Food)·F-1396-2014·2014-01-22

    Jensen's Recalls Unlabeled Hot Smoked Salmon Products

    Jensen's Old Fashioned Smokehouse is recalling Great Ruby Fish Co. and Rolf's Choice hot smoked salmon products that lack 'KEEP FROZEN' labels.

    Product
    Great Ruby Fish Co products are such as Keta and King Hot smoked salmon. No labels provided. Products are labeled with lot code sticker and "KEEP FROZEN" sticker on individual units. The customer applies their own label upon receipt. Rolf's Choice Sockeye hot smoked salmon
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-477-2014·2014-01-22

    FDA Recalls Mislabeled Guaifenesin Tablets Distributed by Aidapak Services

    Aidapak Services is recalling 200 mg Guaifenesin tablets that may be mislabeled as Pancrelipase DR capsules. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.

    Product
    GUAIFENESIN, Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00904515460
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-610-2014·2014-01-22

    Aidapak Recalls Cholecalciferol Capsules Due to Potential Label Mixup

    Aidapak Services, LLC is recalling 50,000-unit Cholecalciferol capsules because they may be mislabeled as Fenofibrate tablets. The repacked drugs were distributed in four western states.

    Product
    CHOLECALCIFEROL Capsule, 50000 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 53191036201
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0725-2014·2014-01-22

    GE Healthcare Recalls Mobile X-ray Systems Due to Software Display Issue

    GE Healthcare is recalling 1,027 Optima XR220amx and XR200amx mobile X-ray systems due to a software issue that may cause patient exams to display incorrectly.

    Product
    GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiographic Systems. Model numbers 5555000-5, 5555000-6, and 5421698.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0758-2014·2014-01-22

    Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors

    The Anspach Effort, Inc. is recalling all lots of MCA Cutting Burrs and Dissection Tools because the indications for use were broader than the device's validation.

    Product
    MCA5-2SB - 2MM Fluted Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0756-2014·2014-01-22

    Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors

    The Anspach Effort, Inc. is recalling MCA Cutting Burrs and Dissection Tools because the indications for use were broader than the device's validation.

    Product
    MCA5-1SB - 1MM Fluted Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0778-2014·2014-01-22

    SpineFrontier Recalls Arena-L Trial Heads Due to Compatibility Issues

    SpineFrontier, Inc. is recalling 23 Arena-L trial heads because they may not be compatible with the trial handles.

    Product
    Arena-L 38x28Trial Head I 10¿ Lordotic; Part: 11-81012-08, 11-81012-10, 11-81012-12, 11-81012-14 The trial heads are smooth plates that mimic the footprint of the implant, manufactured from 17-4 Stainless Steel into 35X26mm (11-81004-XX) and 38X28mm (11-81012-XX) varieties, ea
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-543-2014·2014-01-22

    Aidapak Recalls Cranberry Extract Capsules Due to Label Mixup

    Aidapak Services is recalling Cranberry Extract/Vitamin C capsules because they may be mislabeled as other medications. The products were distributed in four western states.

    Product
    CRANBERRY EXTRACT/VITAMIN C Capsule, 450 mg/125 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 31604014271
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0750-2014·2014-01-22

    Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors

    The Anspach Effort, Inc. is recalling MCA Cutting Burrs and Dissection Tools because their indications for use were broader than validated and directions were unclear.

    Product
    MCA5-05SD - 0.5 MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-621-2014·2014-01-22

    FDA Recalls Tizanidine Tablets Due to Potential Labeling Mixup

    Aidapak Services is recalling Tizanidine HCl tablets because they may be mislabeled as other prescription drugs. The repacked drugs were distributed in four western states.

    Product
    tiZANidine HCl Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 55111017915
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0773-2014·2014-01-22

    GE Healthcare Recalls Imagecast PACS Software Due to Measurement Errors

    GE Healthcare is recalling Imagecast PACS versions prior to 3.6.51.01 because the software fails to account for the estimated magnification factor, leading to inaccurate distance measurements.

    Product
    Imagecast PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0775-2014·2014-01-22

    Lab Vision Estrogen Receptor Antibody Recalled for Performance Issues

    Lab Vision Corporation is recalling Estrogen Receptor AB-11 antibody because in-house testing showed no staining on breast cancer tissues.

    Product
    Estrogen Receptor AB-11 (Clone ID5) Mouse Monoclonal Antibody 1 mk (2mg.ml) Manufactured by: Lab Vision Corporation, Fremont, CA Thermo Fisher Scientific Anatomical Pathology Tudor Rd., Manor Park Rancorn, Cheshire WA7 1TA UK Analyte specific reagent. It is intended
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-743-2014·2014-01-22

    Novartis Recalls Theraflu Nighttime Warming Relief Due to Unknown Degradant

    Novartis Consumer Health is recalling Theraflu Nighttime Warming Relief caplets because an unknown degradant was found during stability testing.

    Product
    Theraflu Nighttime Warming Relief Nighttime Multi-Symptom Cold, Acetaminophen 325mg , Chlorpheniramine Maleate 2mg , Dextromethorphan HBr 10mg , Phenylephrine HCL 5mg, a) 8 coated caplets (NDC 0067-6437-08) b) 24 coated caplets (NDC 0067-6438-24). Distributed by: Novartis Consume
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1426-2014·2014-01-22

    Biery Cheese Co Recalls Shredded Swiss Cheese Due to Foreign Material

    Biery Cheese Co is recalling 5 lb bags of Shredded Swiss Cheese after a customer reported finding foreign yellow plastic material in the product.

    Product
    Shredded Swiss Cheese, INGREDIENTS: Milk, Cheese Culture, Enzymes......Aged 60 days. CONTAINS: MILK NET WT. 80 OZ. (5 LB.) 2.2kg MFG By Biery cheese Co., Louisville, OH 44641
    Category
    Food
    Distribution
    7 states
  • LowFDA (Drugs)·D-738-2014·2014-01-22

    Novartis Recalls Comtrex Cold and Cough Caplets Due to Unknown Degradant

    Novartis Consumer Health is recalling specific lots of Maximum Strength Comtrex Day/Night Cold & Cough caplets because an unknown degradant was found during stability testing.

    Product
    Maximum Strength Comtrex Day/Night Cold & Cough, Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan HBR 10mg, Phenylephrine HCL 5mg, packaged in 16 coated caplets daytime formula and 16 coated caplets nighttime formula *includes antihistamine Distributed by: No
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-739-2014·2014-01-22

    Novartis Recalls Comtrex Nighttime Cold and Cough Due to Unknown Degradant

    Novartis Consumer Health is recalling specific lots of Maximum Strength Comtrex Nighttime Cold & Cough because an unknown degradant was found during stability testing.

    Product
    Maximum Strength Comtrex Nighttime Cold & Cough, Acetaminophen 325mg ,Chlorpheniramine Maleate 2mg, Dextromethorphan HBR 10mg,Phenylephrine HCL 5mg, packaged in 24 coated caplets nighttime formula *includes antihistamine, Distributed by: Novartis Consumer Health, Inc., Parsipp
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-740-2014·2014-01-22

    Novartis Recalls Maximum Strength Comtrex Day/Night Flu Therapy

    Novartis Consumer Health is recalling specific lots of Maximum Strength Comtrex Day/Night Flu Therapy due to an unknown degradant found during stability testing.

    Product
    Maximum Strength Comtrex , Day/Night Flu Therapy , Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan HBr 10mg, Phenylephrine HCL 5mg, packaged in 12 coated caplets daytime formula and 12 coated caplets nighttime formula. Distributed by: Novartis Consumer Health
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-741-2014·2014-01-22

    Novartis Recalls Maximum Strength Comtrex Due to Unknown Degradant

    Novartis Consumer Health is recalling specific lots of Maximum Strength Comtrex Severe Cold & Sinus because an unknown degradant was found during stability testing.

    Product
    Maximum Strength Comtrex ,Severe Cold & Sinus Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Phenylephrine HCL 5mg, packaged in 12 coated caplets daytime formula and 12 coated caplets nighttime formula. Novartis, distributed by: Novartis Consumer Health, Inc., Parsippany, N
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-742-2014·2014-01-22

    Novartis Recalls Theraflu Warming Relief Due to Unknown Degradant

    Novartis Consumer Health is recalling Theraflu Warming Relief caplets because an unknown degradant was found during stability testing.

    Product
    Theraflu Warming Relief, Multi-Symptom Cold, Acetaminophen 325mg, Dextromethorphan HBr 10mg, Phenylephrine HCL 5mg, packaged in a) 8 coated caplets (NDC 0067-6438-08) b) 24 coated caplets (NDC 0067-6438-24), Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-06
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·006-2014·2014-01-19

    Kraft Velveeta Cheeseburger Mac Recalled for Undeclared Soy Allergens

    Truitt Brothers Inc. is recalling approximately 1.77 million pounds of Kraft Velveeta Cheesy Skillets Singles Ultimate Cheeseburger Mac due to misbranding and undeclared soy allergens.

    Product
    Baxters North America — Kentucky Firm Recalls Cheeseburger Mac Products Due To Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·14E002000·2014-01-17

    B&W Recalls Tow & Stow Adjustable Ball Mounts Due to Pin Fracture Risk

    B&W Custom Truck Beds is recalling specific Tow & Stow Adjustable Ball Mounts because the securing pins may fracture, potentially causing the trailer to separate from the vehicle.

    Product
    TRAILER HITCHES recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·005-2014·2014-01-17

    Gusto Packing Recalls Sliced Spiral Hams for Possible Listeria Contamination

    Gusto Packing is recalling approximately 67,113 pounds of sliced spiral ham products due to possible Listeria monocytogenes contamination. The products were distributed in Illinois, Indiana, Kentucky, Ohio, and Canada.

    Product
    Carl Buddig and Company — Illinois Firm Recalls Sliced Spiral Hams for Possible Listeria Contamination
    Category
    Food
    Distribution
    4 states
  • HighUSDA FSIS·004-2014·2014-01-17

    Huong Duyen Recalls Beef and Pork Products for Undeclared Wheat Allergen

    Huong Duyen Meat Products is recalling approximately 130,000 pounds of beef and pork products because they contain undeclared wheat, a known allergen.

    Product
    Huong Duyen Meat Products — Colorado Firm Recalls Beef and Pork Products Due To Misbranding and Undeclared Allergen
    Category
    Food
    Distribution
    3 states
  • HighNHTSA·14V003000·2014-01-17

    EverGreen Recalls 2013 Travel Trailers Due to Door Lock Jamming Risk

    EverGreen is recalling 2013 travel trailers because a door lock defect could jam the deadbolt, trapping occupants inside the vehicle.

    Product
    EVERGREEN — EVERGREEN EVER-LITE SELECT, ASCEND, I-GO, EVER-LITE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V010000·2014-01-16

    Aston Martin Recalls Multiple Models Due to Accelerator Pedal Arm Defect

    Aston Martin is recalling specific 2008-2014 models because a manufacturing error may cause the accelerator pedal arm to break, preventing the driver from maintaining or increasing engine speed.

    Product
    ASTON MARTIN — ASTON MARTIN V8 VANTAGE S, RAPIDE S, V12 VANTAGE COUPE, DB9
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14081·2014-01-16

    Philips Selecon Recalls Stage Light Barndoors Due to Impact Hazard

    Philips Selecon is recalling four- and eight-leaf barndoors for Rama stage lights because heat can cause them to detach and fall, posing an impact injury risk.

    Product
    Stage Light Barndoors
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·14711·2014-01-16

    Bosch Recalls Fire Alarm Control Panels Due to Alarm Failure Risk

    Bosch Security Systems is recalling approximately 2,000 GV4 Fire Alarm Control Panels because a specific module may prevent audible or visual alarms from sounding during a fire.

    Product
    Bosch GV4 Fire Alarm Control Panels
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-403-2014·2014-01-15

    FDA Recalls Super Triple Mix Injectable Due to Sterility Concerns

    The FDA is recalling all lots of Super Triple Mix Injectable from The Compounding Center at Blue Ridge due to quality control concerns regarding sterility assurance.

    Product
    Super Triple Mix Injectable, (aka Dr Lentz Triple Rx Injectable; Dr Kane's Super Triple Rx Injectable; Dr Tortora's Super Triple Rx Injectable), 5 mL vial, Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-404-2014·2014-01-15

    Quad Mix Injectable Recalled Due to Sterility Concerns

    The Compounding Center at Blue Ridge is recalling all lots of Quad Mix Injectable due to quality control concerns identified during an FDA inspection.

    Product
    Quad Mix Injectable, 5 mL, Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0679-2014·2014-01-15

    ICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needleless Connectors because a small percentage of devices may leak. The affected units were distributed worldwide.

    Product
    8" Ext Set w/NanoClave" Stopcock, Clamp, Rotating Luer, Part No. A1000, Item No. AC102 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient
    Category
    Medical Device
    Distribution
    14 states
  • SevereFDA (Devices)·Z-0683-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling NanoClave Needlefree Connectors because a small percentage of devices may leak. The affected units were distributed worldwide.

    Product
    7" (18 cm) Appx 0.26 ml, Smallbore Ext Set w/MicroClave¿ Clear, NThe ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula place
    Category
    Medical Device
    Distribution
    14 states
  • SevereUSDA FSIS·003-2014·2014-01-15

    Cloverdale Foods Recalls Beef Franks Due to Undeclared Milk Allergen

    Cloverdale Foods is recalling approximately 2,664 pounds of beef franks because the label fails to declare milk, a known allergen. No adverse reactions have been reported.

    Product
    Cloverdale Foods Co. — North Dakota Firm Recalls Beef Franks Due To Misbranding and Undeclared Allergen
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1380-2014·2014-01-15

    ANAT Recalls Tribulus Supreme 2.0 Supplements Due to Chloramphenicol Contamination

    ANAT, LLC is recalling IMT Wellness Tribulus Supreme 2.0 dietary supplements due to potential chloramphenicol contamination. The product was distributed in Connecticut.

    Product
    IMT Wellness Tribulus Supreme 2.0** GI & Immune Support ** Dietary Supplements 60 Vegetarian Capsules *** Distributed by: ANAT, LLC Bloom field, CT
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0650-2014·2014-01-15

    Nova Hospital Blood Glucose Meters Recalled for Battery Swelling and Leakage

    Nova Biomedical is recalling hospital blood glucose meters due to battery swelling and cell leakage. The recall covers approximately 200,000 units distributed nationwide.

    Product
    Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactate Hospital Meter System; Nova StatSensor Creatinine Hospital Meter, Rechargeable Lithium Batteries Single: 46626; 4 Pack: 46827; 5 Pack: 50436. For Point-Of-Care usage in the quantitative determin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1382-2014·2014-01-15

    Innovative Labs Recalls Terrain Zyme LGS-Zyme Dietary Supplement

    Innovative Labs, LLC is recalling Terrain Zyme LGS-Zyme dietary supplements due to the presence of Chloramphenicol, an antimicrobial agent.

    Product
    Terrain Zyme LGS-Zyme (Z-12), Enzyme-Based Multivitamin & Amino Acid Dietary Supplement, packaged as 120 capsules per bottle. Distributed by Apex Energetics, Inc. 16592 Hale Avenue, Irvine CA 92606.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0694-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.

    Product
    7" (18 cm) Appx 0.33 ml, Smallbore Ext Set w/NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. K7103-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administr
    Category
    Medical Device
    Distribution
    14 states
  • SevereFDA (Drugs)·D-401-2014·2014-01-15

    Triple Mix Injectable Recalled for Lack of Sterility Assurance

    The Compounding Center at Blue Ridge is recalling 92 units of Triple Mix Injectable due to quality control concerns identified during an FDA inspection.

    Product
    Triple Mix Injectable (aka Dr Ungers Triple Rx; Dr Tortora's Triple Rx; Dr Bennett's Triple Rx; Dr Neighbors Triple Rx Injectable; Dr Leatherman's Triple Rx Injectable; Dr Kane's Triple Rx Injectable; Dr Khoudary's Triple Rx Injectable) Rx Only, The Compounding Center at Blue Ri
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-402-2014·2014-01-15

    FDA Recalls PGE Injectable Due to Sterility Assurance Concerns

    The Compounding Center at Blue Ridge is recalling PGE 20 mcg/mL and 40 mcg/mL injectables due to quality control concerns regarding sterility assurance identified during an FDA inspection.

    Product
    PGE 20 mcg/mL Injectable, 10 mL, and PGE 40 mcg/mL, 5 mL, Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0654-2014·2014-01-15

    Anspach Pneumatic Drill System Recalled Due to Hose Rupture Risk

    The Anspach Effort, Inc. is voluntarily removing Pneumatic Drill Systems from the market because the outer hose on the motor hand-piece can rupture without warning if air flow is blocked.

    Product
    ***REF BLACKMAX-N***Swivel/Angle Motor Assembly***Rx Only***The Anspach Effort, Inc. Intended for cutting and shaping bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1381-2014·2014-01-15

    Innovative Labs Recalls Terrain Zyme Myco-Zyme Due to Chloramphenicol

    Innovative Labs, LLC is recalling Terrain Zyme Myco-Zyme dietary supplements because they contain Chloramphenicol, an antimicrobial agent.

    Product
    Terrain Zyme Myco-Zyme (Z-13), Enzyme-Based Herbal Dietary Supplement, packaged as 90 capsules per bottle. Distributed by Apex Energetics, Inc. 16592 Hale Avenue, Irvine CA 92606.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-397-2014·2014-01-15

    Watson Recalls Carisoprodol Tablets Due to Metal Particulates

    Watson Laboratories is recalling 4,439 bottles of Carisoprodol Tablets because metal particulates were visually observed in the tablets.

    Product
    Carisoprodol Tablets, USP, CIV, 350 mg, 500 count bottle, Rx only. Manufactured by Watson Pharma Private Ltd, Verna, Salcette, Goa, 403 722 INDIA. Distributed by: Watson Pharma Ltd, Parsippany, NJ 07054. NDC 0591-5513-05.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0631-2014·2014-01-15

    Anspach BLACKMAX-N Pneumatic Motor Recalled for CJD Exposure Risk

    The Anspach Effort, Inc. is recalling four BLACKMAX-N pneumatic motors and one Autolube III foot control used in a case involving a patient with Creutzfeldt-Jacob Disease.

    Product
    Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control). Cutting and shaping bone.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Drugs)·D-405-2014·2014-01-15

    FDA Recalls Papaverine/Phentolamine Injections Due to Sterility Concerns

    The Compounding Center at Blue Ridge is recalling all lots of Papaverine/Phentolamine injections due to quality control concerns regarding sterility assurance identified during an FDA inspection.

    Product
    Papaverine/Phentolamine 30 mg/mL/2.0 mg/mL Inj, 5 mL units Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-0656-2014·2014-01-15

    Anspach Effort Pneumatic Drill System Recalled Due to Hose Rupture Risk

    The Anspach Effort, Inc. is voluntarily removing the microMax Pneumatic Drill System because the outer hose may rupture without warning if airflow is blocked.

    Product
    ***REF MICROMAX***microMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended for cutting and shaping bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·14710·2014-01-15

    Honda and Columbia Walk-Behind Lawnmowers Recalled for Laceration Hazard

    American Honda is recalling specific 21-inch walk-behind lawnmowers because the engine stop switch can malfunction, allowing the blade to keep rotating after the control lever is released.

    Product
    Walk-behind 21" lawnmowers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0611-2014·2014-01-15

    Puritan Bennett 840 Ventilator Software Recall for Diagnostic Code XB0069

    Covidien is recalling Puritan Bennett 840 ventilators with specific software revisions because a software error causes the device to stop mechanical ventilation.

    Product
    Puritan Bennett 840 ventilator systems software part number 4-070212-85, revision AB-AG. The intended use of the product is to provide mechanical ventilation to patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0652-2014·2014-01-15

    ArthroCare Knot Pusher Recalled Due to Sharp Edge Hazard

    ArthroCare Medical Corporation is recalling 76 units of the SPORTS MEDICINE Knot Pusher because a sharp edge on the tip may damage or cut a suture.

    Product
    Arthrocare SPORTS MEDICINE, Knot Pusher, REF 25-3011, LOT #1049402, CON 1, 2013-10, NON-STERILE, Rx only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0638-2014·2014-01-15

    Sandel Weighted Safety Scalpels Recalled Due to Exposed Blades

    Ansell Sandel Medical Industries is recalling Sandel Weighted Safety Scalpels because the blades may be exposed, compromising sterility and causing injury.

    Product
    Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #11 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0677-2014·2014-01-15

    ICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needleless Connectors because a small percentage of devices may leak.

    Product
    14" (36 cm ) Appx 0.50 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave¿, 2 Clamps, Rotating Luer, Part No. A1000, Item No. A1081 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration se
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0643-2014·2014-01-15

    Smiths Medical Recalls Insulin Syringes With Visible Particulate on Needles

    Smiths Medical ASD, Inc. is recalling 93,700 units of Hypodermic Needle-Pro Fixed Needle Insulin Syringes due to visible orange or brown particulate on the needles.

    Product
    Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.3ml 29g x 1/2 in Reference: 4429-3 Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The sy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0674-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of the devices may leak.

    Product
    10" Smallbore Pentafuse Ext Set w/5 NanoClave", 5 Clamps, Rotating Luer, Part No. A1000, Item No. A1071 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of flu
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0491-2014·2014-01-15

    Carestream DRX-Revolution Mobile X-Ray Systems Recalled for Image Retrieval Failure

    Carestream Health Inc. is recalling 310 mobile X-ray systems because processed images could not be found, leading to patient re-exposure.

    Product
    Carestream DRX-Revolution Mobile X-Ray System -- Made in U.S.A. by Carestream Health Inc. 150 Verona Street, Rochester, NY . 14608 --- The DRX Revolution Mobile system is a mobile diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. Thes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0621-2014·2014-01-15

    Integra Small Rickham-Style Reservoirs Recalled for Bent or Broken Connectors

    Integra LifeSciences is recalling 194 packages of Small Rickham-Style Reservoirs due to bent or broken connectors found after opening the sterile package.

    Product
    Integra Small Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Made in the USA NL 850-1121 Provides access to the lateral cerebral ventricles via hypodermic puncture. It is useful in obtaining C
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-0702-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling NanoClave Needlefree Connectors because a small percentage of devices may leak.

    Product
    5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Luer Slip, Item # B3303-T, Lot # 2791243. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0651-2014·2014-01-15

    Midmark Vantage Panoramic X-Ray System Recalled for Firmware Error

    Midmark Corp dba Progeny Inc is recalling 58 Vantage Panoramic X-Ray systems due to a firmware error that may cause the unit's column to continue moving vertically after the control button is released.

    Product
    The Vantage Digital Panoramic System delivers high-value features standard on every system: - Five pre-programmed exam settings, including bitewing, minimize exam set-up time and allow routine diagnostic exams to be performed extraorally for improved clinical efficiency and patie
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0632-2014·2014-01-15

    Anspach Craniotome Recalled After Use in Creutzfeldt-Jakob Disease Case

    The Anspach Effort, Inc. is recalling specific craniotome attachments used in a case involving a patient with Creutzfeldt-Jakob Disease.

    Product
    Anspach B-Blue-S 11.25 cm attachment and Anspach B-Green Standard Craniotome. Cutting and shaping bone.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0700-2014·2014-01-15

    ICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needleless Connectors because a small percentage of devices may leak.

    Product
    5" (13 cm) Appx 0.23 ml, Smallbore Ext Set w/NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. Z3845 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administratio
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0629-2014·2014-01-15

    Fresenius 2008 Series Hemodialysis Machines Recalled for Saline Bag Filling Issues

    Fresenius Medical Care is recalling 2008 Series Hemodialysis Machines because saline bags may fill inappropriately during setup and recirculation.

    Product
    Fresenius 2008 Series Hemodialysis Machines: Models: 2008H, 2008K, 2008K2, 2008k@Home, 2008T The 2008H Hemodialysis machine is indicated for acute and chronic dialysis therapy. Hemodialysis is indicated for patients with acute or chronic renal failure, when conservative thera
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0691-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaks

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.

    Product
    7" (18 cm) Appx 0.31 ml, Smallbore Ext Set w/2 NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. K7099-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administr
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0644-2014·2014-01-15

    Smiths Medical Recalls Insulin Syringes With Visible Particulate on Needles

    Smiths Medical is recalling 29-gauge insulin syringes due to visible orange or brown particulate on the needles. The recall covers 506,925 units distributed in the US, Canada, Italy, and Spain.

    Product
    Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 in Reference: 4429-5 Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The sy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0682-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.

    Product
    7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. K7088-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set
    Category
    Medical Device
    Distribution
    14 states
  • HighNHTSA·14V009000·2014-01-15

    Triumph Recalls 2012-2014 Tiger and Trophy Motorcycles for ECU Defect

    Triumph is recalling 2012-2014 Tiger and Trophy motorcycles because a faulty electronic control unit may cause the engine to shut down unexpectedly, increasing crash risk.

    Product
    TRIUMPH — TRIUMPH TIGER, TROPHY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1378-2014·2014-01-15

    Baugher Ranch Organic Almonds Recalled for Potential Metal Fragments

    Baugher Ranch Organics is recalling 80 cases of organic almonds due to a broken metal detector wire that may have introduced metal fragments into the product.

    Product
    Organic Almonds: Baugher Ranch Organics; Certified Organic by California Organic Farmers May Contain occasional Shell fragments. Keep Refrigerated; 25 lbs. Baugher Farms, Orland, CA
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1645-2013·2014-01-15

    Creole Bisque Recalled for Undeclared Milk, Soy, and Wheat Allergens

    Creole & Company is recalling Creole Bisque because it contains milk, soy, and wheat without an ingredient statement declaring their presence.

    Product
    Creole & Company Creole Bisque, NET WEIGHT 3.47 oz (98g), manufacture for: Creole & Company, 145 Robert E. Lee Blvd. Penthouse Suite, New Orleans, LA 70124, UPC: 811773014869
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0684-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaks

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.

    Product
    7" (18 cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave" T-Connector, Clamp, Rotating Luer, Part No. A1000, Item No. K7090-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular a
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0701-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.

    Product
    5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Rotating Luer, Item # B33101-T, Lot # 2791358. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of flu
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0660-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.

    Product
    6" (15 cm) Appx 0.58 ml, Smallbore Trifuse Ext Set w/3 NanoClave¿, 3 Clamps, Rotating Luer, Part No. A1000, Item No. 011-A1029 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for th
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0687-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak. The affected units were distributed worldwide.

    Product
    78" Ext Set w/2 BCV-Clave¿, Remv 2-Gang 4-Way Stopcocks, NanoClave" T-Connector, 4 Clamps, Rotating Luer, 3 Exts, Part No. A1000, Item No. K7094-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular ad
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0664-2014·2014-01-15

    ICU Medical Recalls NanoClave Stopcock Due to Potential Leakage

    ICU Medical is recalling specific lots of NanoClave Stopcocks because a small percentage of the devices may leak.

    Product
    NanoClave Stopcock, Part No. A1000, Item No. 011-AC100 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the v
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0686-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of the devices may leak.

    Product
    106" (269 cm) Appx 7.8 ml, Transfer Set w/Check Valve, NanoClave" TConnector, Anti-Siphon Valve, 2 Clamps, Luer Lock, Part No. A1000, Item No. K7093-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0696-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.

    Product
    13" Pentafuse Smallbore Ext Set w/NanoClave", 1.2 Micron Filter, 3 MicroClave¿ Clear (Yellow, Red, Green Rings), 6 Clamps, Rotating Luer, Part No. A1000, Item No. K7106-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an acce
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0634-2014·2014-01-15

    Invacare Recalls Tracer IV Wheelchairs Due to Warped Wheels

    Invacare is recalling 227 Tracer IV wheelchairs in Michigan because the wheels were warped and wobbled when rolled.

    Product
    Tracer IV wheelchairs, Heavy duty manual wheel chair, 24" seat width, 450 lbs. weight capacity. Distributed by Invacare, Elyria, OH 44035 For transportation to accomplish necessary tasks of daily living in a home or community environment for the user.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0698-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.

    Product
    30" (76 cm) Appx 3.7 ml, Ext Set w/Remv 2 Gang CLAVE¿ Stopcock, Remv CLAVE¿ Stopcock, NanoClave¿ T-Connector, Rotating Luer, 1 Ext, Part No. A1000, Item No. SC124 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0681-2014·2014-01-15

    ICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needleless Connectors because a small percentage of devices may leak.

    Product
    6" (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave" TConnector w/Luer Slip, Part No. A1000, Item No. K7085-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the ad
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0626-2014·2014-01-15

    Siemens HbA1c Flex Reagent Cartridge Recall for Positive Bias

    Siemens is recalling HbA1c Flex reagent cartridges due to positive bias and frequent out-of-range flags, which may affect diabetes monitoring.

    Product
    HbA1c Flex(R) reagent cartridge (K3105A, Siemens Material Number 10470481) for the Dimension(R) Clinical Systems. Dimension(R) Hemoglobin A1c (HB1C) Flex(R) reagent Cartridge on the Dimension(R) clinical chemistry system is an in vitro diagnostic assay for the quantitative det
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0655-2014·2014-01-15

    Anspach Effort Pneumatic Drill System Recalled Due to Hose Rupture Risk

    The Anspach Effort, Inc. is voluntarily removing Pneumatic Drill Systems because the outer hose can rupture without warning if airflow is blocked.

    Product
    ***REF XMAX***XMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended for cutting and shaping bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0688-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.

    Product
    7" (18 cm) Appx 0.24 ml, Smallbore Ext Set w/NanoClave", Clamp, Luer Lock, Part No. A1000, Item No. K7095-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0690-2014·2014-01-15

    ICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needleless Connectors because a small percentage of the devices may leak.

    Product
    6" (15 cm) Appx 0.56 ml, Smallbore Trifuse Ext Set w/3 NanoClave", 3 Clamps, Luer Lock, Part No. A1000, Item No. K7097-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the ad
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0672-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of the devices may leak.

    Product
    8" (20 cm) Appx 0.49 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock, Part No. A1000, Item No. A1069 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the adminis
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0636-2014·2014-01-15

    Sandel Weighted Safety Scalpels Recalled for Exposed Blades

    Ansell Sandel Medical Industries LLC is recalling Sandel Weighted Safety Scalpels because the blade may be exposed beyond the safety shield, compromising sterility and causing injury.

    Product
    Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #11 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0658-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of the devices may leak.

    Product
    NanoClave Connector, Part No. A1000, Item No. 011-A1000, 061-A1000, A1000, K7083-001, Z3769 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a pa
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0659-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.

    Product
    6" (15 cm) Appx 0.26 ml, Smallbore Ext Set with NanoClave T-Connector, Clamp, Luer Slip, Part No. A1000, Item No. 011-A1002 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the a
    Category
    Medical Device
    Distribution
    14 states

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