The Recall Desk

Archive

January 2014 recalls

1,423 recalls were announced in January 2014.

What the numbers show

Critical
159
Severe
434
High
277
Moderate
532
Low
21

Of the 1,423 recalls this month scored against our rubric, 11% are Critical, 30% are Severe.

801–900 of 1423

  • ModerateFDA (Drugs)·D-468-2014·2014-01-22

    Coenzyme Q-10 Capsules Recalled for Potential Labeling Error

    Aidapak Services is recalling Coenzyme Q-10 capsules that may be mislabeled as Pancrelipase DR due to a label mixup.

    Product
    COENZYME Q-10, Capsule, 30 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904501546
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-688-2014·2014-01-22

    Aidapak Recalls Multivitamin Tablets Due to Potential Labeling Errors

    Aidapak Services is recalling specific lots of multivitamin tablets because they may be mislabeled as other prescription medications.

    Product
    MULTIVITAMIN/MULTIMINERAL LOW IRON Tablet, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 64376081601
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-670-2014·2014-01-22

    Aidapak Recalls Isosorbide Mononitrate Tablets Due to Potential Labeling Errors

    Aidapak Services, LLC is recalling Isosorbide Mononitrate 20 mg tablets because they may be mislabeled as other medications. The affected repacked drugs were distributed in four western states.

    Product
    ISOSORBIDE MONONITRATE, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 62175010701
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-660-2014·2014-01-22

    Cilostazol Tablets Recalled for Potential Labeling Mixup with Dutasteride

    Aidapak Services is recalling Cilostazol 100 mg tablets because they may be mislabeled as Dutasteride 0.5 mg capsules.

    Product
    CILOSTAZOL Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60505252201
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0776-2014·2014-01-22

    SpineFrontier Recalls Arena-L Trial Handles and Heads Due to Compatibility Issues

    SpineFrontier, Inc. is recalling 23 Arena-L Trial Handles and Heads because the components may not be compatible. The devices were distributed only to the U.S. Department of Veterans Affairs.

    Product
    Arena-L Trial Handle; Part: 11-81002 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, each with multiple height configurations. The Trial Heads are…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-591-2014·2014-01-22

    Aidapak Recalls Mislabeled HydrALAZINE HCl Tablets

    Aidapak Services, LLC is recalling hydrALAZINE HCl 50 mg tablets that may be mislabeled as CapsuleTOPRIL 12.5 mg tablets.

    Product
    hydrALAZINE HCl Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 50111032801
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-506-2014·2014-01-22

    FDA Recalls Chlorophyllin Copper Complex Tablets Due to Labeling Error

    Aidapak Services, LLC is recalling Chlorophyllin Copper Complex tablets that may be mislabeled as trazodone hydrochloride.

    Product
    CHLOROPHYLLIN COPPER COMPLEX, Tablet, 100 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 11868000901
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-507-2014·2014-01-22

    Aidapak Recalls Paroxetine Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Paroxetine HCl 10 mg tablets because they may be mislabeled as Pantoprazole Sodium DR 20 mg.

    Product
    PARoxetine HCl, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 13107015430
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-587-2014·2014-01-22

    Doxepin HCL Capsules Recalled for Potential Label Mixup

    Aidapak Services is recalling Doxepin HCL capsules due to a labeling error where they may be mislabeled as Valsartan tablets.

    Product
    DOXEPIN HCL Capsule, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 49884022201
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-493-2014·2014-01-22

    FDA Recalls Bisacodyl Tablets Due to Potential Labeling Error

    Aidapak Services, LLC is recalling 100-tablet bottles of Bisacodyl EC 5 mg tablets because they may be mislabeled as Cholecalciferol 400 units.

    Product
    BISACODYL EC, Tablet, 5 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904792760
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-681-2014·2014-01-22

    Lurasidone HCl Tablets Recalled for Potential Labeling Mixup

    Aidapak Services is recalling Lurasidone HCl 120 mg tablets because they may be mislabeled as Duloxetine HCl DR 20 mg capsules.

    Product
    LURASIDONE HCL, Tablet, 120 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63402031230
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-684-2014·2014-01-22

    FDA Recalls GuaiFENesin ER Tablets Due to Potential Labeling Mixup

    Aidapak Services, LLC is recalling GuaiFENesin ER tablets because they may be mislabeled as Omega-3 acid ethyl esters capsules.

    Product
    guaiFENesin ER Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63824000850
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-540-2014·2014-01-22

    Aidapak Recalls Caffeine Tablets Due to Potential Labeling Errors

    Aidapak Services, LLC is recalling 200 mg caffeine tablets because they may be mislabeled as other medications. The repacked drugs were distributed in four western states.

    Product
    CAFFEINE Tablet, 200 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 24385060173
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-629-2014·2014-01-22

    Aidapak Recalls Metoprolol Tablets Due to Potential Label Mixup

    Aidapak Services is recalling Metoprolol Tartrate 25 mg tablets because they may be mislabeled as Ascorbic Acid or Amlodipine Besylate.

    Product
    METOPROLOL TARTRATE Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 57664050652
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-631-2014·2014-01-22

    FDA Recalls Isosorbide Dinitrate Tablets Due to Labeling Error

    Aidapak Services is recalling Isosorbide Dinitrate ER tablets because they may be mislabeled as Cilostazol. Patients should check their medication labels.

    Product
    ISOSORBIDE DINITRATE ER Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 57664060088
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0764-2014·2014-01-22

    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
    MCA7-15SB - 1.5MM Fluted Ball, 7.3CM. 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-729-2014·2014-01-22

    Fluconazole Tablets Recalled Due to Potential Labeling Mixup

    Aidapak Services is recalling Fluconazole 100 mg tablets because they may be mislabeled as Prenatal Multivitamin/Multimineral tablets.

    Product
    FLUCONAZOLE, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68462010230
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-699-2014·2014-01-22

    Aidapak Recalls Phosphorus Tablets Due to Potential Label Mixup

    Aidapak Services is recalling 250 mg Phosphorus tablets because they may be mislabeled as other prescription drugs. The repacked drugs were distributed in four western states.

    Product
    PHOSPHORUS Tablet, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64980010401
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-516-2014·2014-01-22

    Venlafaxine Tablets Recalled for Potential Labeling Mixup

    Aidapak Services is recalling Venlafaxine 25 mg tablets because they may be mislabeled as Omeprazole/Sodium Bicarbonate capsules.

    Product
    VENLAFAXINE Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714031101
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-700-2014·2014-01-22

    Lactobacillus Tablets Recalled for Potential Labeling Errors

    Aidapak Services, LLC is recalling Lactobacillus tablets due to a label mixup that may cause them to be mislabeled as other medications.

    Product
    LACTOBACILLUS Tablet, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 64980012950
    Category
    Drug
    Distribution
    4 states
  • 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 (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-585-2014·2014-01-22

    Aidapak Recalls Aspirin EC Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Aspirin EC DR tablets because they may be mislabeled as Melatonin or Docusate Sodium.

    Product
    ASPIRIN EC DR Tablet, 81 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 49348098015
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-599-2014·2014-01-22

    Aidapak Recalls Pyridoxine HCL Tablets Due to Labeling Mixup

    Aidapak Services, LLC is recalling Pyridoxine HCL 50 mg tablets because they may be mislabeled as other medications. The repacked drugs were distributed in four western states.

    Product
    PYRIDOXINE HCL Tablet, 50 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 51645090901
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-553-2014·2014-01-22

    Aidapak Recalls Omega-3 Fatty Acid Capsules Due to Labeling Error

    Aidapak Services, LLC is recalling Omega-3 Fatty Acid Capsules, 1000 mg, because they may be mislabeled as other medications. The affected products were distributed in Arizona, California, Oregon, and Washington.

    Product
    OMEGA-3 FATTY ACID Capsule, 1000 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 40985022921
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-535-2014·2014-01-22

    Aidapak Recalls Multivitamin Capsules Due to Potential Label Mixup

    Aidapak Services, LLC is recalling specific lots of multivitamin capsules that may be mislabeled as caffeine or melatonin tablets.

    Product
    MULTIVITAMIN/ MULTIMINERAL/ LUTEIN Capsule, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 24208063210
    Category
    Drug
    Distribution
    4 states
  • 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.…
    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…
    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…
    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.…
    Category
    Drug
    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…
    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…
    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
  • SevereUSDA 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 VIRAGE, DBS, DB9, RAPIDE
    Category
    Vehicle
    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
  • 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
  • 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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
  • 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 (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…
    Category
    Drug
    Distribution
    1 state
  • 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…
    Category
    Medical Device
    Distribution
    14 states
  • 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 (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
  • 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-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 (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 (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 (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-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
  • 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-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…
    Category
    Medical Device
    Distribution
    14 states
  • 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 (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-0685-2014·2014-01-15

    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
    10" (25 cm) Appx 2.9 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, Tri- Connector, NanoClave" T-Connector, 4 Clamps (Red, White, Blue), Rotating Luer, Part No. A1000, Item No. K7091-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use…
    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…
    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…
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Food)·F-1379-2014·2014-01-15

    ANAT LLC Recalls IMT Wellness Legume Digest 2.0 Due to Chloramphenicol Risk

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

    Product
    IMT Wellness Legume Digest 2.0** Dietary Supplements 120 Vegetarian Capsules *** Distributed by: ANAT, LLC Bloom field, CT; in a white 150 cc bottle with white cap
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0646-2014·2014-01-15

    Smiths Medical Insulin Syringes Recalled for Visible Particulate on Needles

    Smiths Medical is recalling 54,000 Hypodermic Needle-Pro insulin syringes due to visible orange or brown particulate on the needles.

    Product
    Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 in. Distributed by: Cardinal Health, Dublin, OH (Co-Brand) Reference: ED052905IN Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0680-2014·2014-01-15

    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 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave" TConnector, Rotating Luer, Part No. A1000, Item No. K7084-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for…
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0704-2014·2014-01-15

    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
    28" (71 cm) Appx 1.0 ml, Smallbore Ext Set w/Anti-Siphon Valve, MicroClave¿ T-Connector, Clamp, Rotating Luer, Item # B33071-T, Lot # 2791245. 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-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-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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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…
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0705-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Leakage Risk

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

    Product
    6.5" (16.5 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave¿ Clear, NanoClave¿ T-Connector, Purple Clamp, Rotating Luer, Item # A1099, Lot # 2791393. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for…
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0666-2014·2014-01-15

    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 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave¿ TConnector, Rotating Luer, Part No. A1000, Item No. A1001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the…
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0635-2014·2014-01-15

    Sandel Weighted Safety Scalpels Recalled Due to Exposed Blades

    Ansell Sandel Medical Industries is recalling specific lots of Sandel Weighted Safety Scalpels because the blades are exposed beyond the safety shield, potentially compromising sterility and causing injury.

    Product
    Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #10 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-0645-2014·2014-01-15

    Smiths Medical Insulin Syringes Recalled for Visible Particulate on Needles

    Smiths Medical is recalling 108,000 Hypodermic Needle-Pro insulin syringes due to visible orange or brown particulate on the needles.

    Product
    Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2 in Distributed by: Cardinal Health, Dublin, OH (Co-Brand) Reference: ED012905-IN Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0675-2014·2014-01-15

    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
    87" (221 cm) Appx 2.9 ml, Smallbore Trifuse Ext Set w/NanoClave¿, 0.2 Micron Filter, 4 Clamps, Rotating Luer, 2 Exts, Drop-In NanoClave¿, Part No. A1000, Item No. A1078 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory…
    Category
    Medical Device
    Distribution
    14 states
  • 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…
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0532-2014·2014-01-15

    Trans American Medical Recalls Spectre Wireless Footswitches Due to Uncommanded X-ray Risk

    Trans American Medical is recalling 68 Spectre Wireless Footswitch/Handswitch units because they may produce uncommanded X-rays.

    Product
    Spectre Wireless Footswitch/Handswitch system Model 98/99, Model FDS, Model FDB. The Spectre Wireless Encrypted Footswitch/Hand Switch System is a prescription use system and intended only for use with the system indicated in the model number
    Category
    Medical Device
    Distribution
    2 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…
    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…
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0640-2014·2014-01-15

    Sandel Weighted Safety Scalpels Recalled for Exposed Blades

    Ansell Sandel Medical Industries is recalling Sandel Weighted Safety Scalpels because the blades are exposed beyond the safety shield, potentially compromising sterility and causing injury.

    Product
    Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long Disposable Safety Handle with #15 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0642-2014·2014-01-15

    Smiths Medical Recalls Insulin Syringes Due to Visible Particulate on Needles

    Smiths Medical is recalling specific lots of Hypodermic Needle-Pro Fixed Needle Insulin Syringes because visible orange or brown particulate was found on the needles.

    Product
    Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2 in Reference: 4429-1 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0678-2014·2014-01-15

    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
    103" (262 cm) Appx 3.9 ml, Smallbore Bifuse Ext Set w/NanoClave", Anti-Siphon Valve, Check Valve, 2 Clamps, Luer Lock, Part No. A1000, Item No. A1093 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-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…
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0667-2014·2014-01-15

    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
    7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave¿, Clamp, Rotating Luer, Part No. A1000, Item No. A1007 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for…
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0633-2014·2014-01-15

    Welch Allyn Propaq LT Series Monitors Recalled for Potential Operational Interruption

    Welch Allyn is updating software on Propaq LT Series monitors because rare hardware or software faults could interrupt device operations.

    Product
    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • HighFDA (Devices)·Z-0703-2014·2014-01-15

    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 # B3304-T, Lot # 2791244. 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…
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0707-2014·2014-01-15

    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 the devices may leak.

    Product
    17 cm (7") Smallbore Trifuse Ext Set w/3 NanoClave¿ ( Light Blue, Lavender Rings), 3 Anti-Syphon Valves, Rotating Luer, Item #011-A1096, Lot # 2796668. 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-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-0695-2014·2014-01-15

    ICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaks

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

    Product
    11" Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave", 3 Clamps, Rotating Luer, Part No. A1000, Item No. K7105-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the…
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0648-2014·2014-01-15

    GE Healthcare Recalls Patient Data Modules Due to Heat Buildup Risk

    GE Healthcare is recalling 17,444 Patient Data Modules used with SOLAR 8000 and Transport Pro monitors. The recall addresses a potential safety issue where fluid ingress can cause heat buildup.

    Product
    SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0671-2014·2014-01-15

    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
    11" Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave", 3 Clamps, Rotating Luer, Part No. A1000, Item No. A1052 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the…
    Category
    Medical Device
    Distribution
    14 states
  • 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
  • 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 (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…
    Category
    Medical Device
    Distribution
    14 states
  • 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…
    Category
    Medical Device
    Distribution
    13 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-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…
    Category
    Medical Device
    Distribution
    14 states

Looking for a different month? Back to 2014.