W L Gore & Associates, Inc. recalls Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal…
Incorrect labeling, specifically, expandable endoprosthesis labeled as 8 mm x 59mm x 135 cm, however may contain a 9mm x 29 mm x 135 cm device.
Read the official notice →- Date
- 2021-10-20
- Country
- United States
- Brand
- W L Gore & Associates
- Product
- Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent…
- Classification
- Class II
- Units
- International distribution to the countries of Italy & Lebanon.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More W L Gore & Associates recalls
- 2024-09-11
USW L Gore & Associates, Inc. recalls Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB051501A…
Due to packaging defects, sterility assurance and heparin activity may be compromised.
FDA · DeviceW L Gore & Associates, Inc.Worldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice →- 2024-08-14
- US
W.L. Gore & Associates, Inc. recalls GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;
Devices were labeled with an expiration date of four years and ten days rather than the validated two years.
FDA · DeviceW.L. Gore & Associates, Inc.US Nationwide distribution in the states of CA, GA, IL, NC, OH, OK, WA.Official notice → - 2024-02-28
- US
W.L. Gore & Associates, Inc. recalls GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm; with holes; and (2)…
Devices without transmural drainage holes may be mislabeled as devices with transmural drainage holes, or vice versa. Potential health impact includes extending procedure time, unplanned device removal, secondary…
FDA · DeviceW.L. Gore & Associates, Inc.US Nationwide distribution in the state of Georgia.Official notice → - 2023-02-08
- US
W L Gore & Associates, Inc. recalls GORE CARDIOFORM Septal Occluder, REF: GSX0030A
Septal Occluders released with incomplete quality test documentation that assesses the release of the device from the delivery system during the index procedure. A potential failure of this quality test could…
FDA · DeviceW L Gore & Associates, Inc.US Nationwide distribution in the states of NY, CA, FL, CT, TX, AR, IN, MA,…Official notice → - 2022-11-02
- US
W L Gore & Associates, Inc. recalls GORE CARDIOFORM ASD Occluder. cardiovascular implant.
Due to manufacturing records (Release Test Results) indicating "Failed".
FDA · DeviceW L Gore & Associates, Inc.Worldwide distribution - U.S. Nationwide distribution including in the states…Official notice → - 2021-11-03
- US
W L Gore & Associates, Inc. recalls REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr,…
Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
FDA · DeviceW L Gore & Associates, Inc.US: AL,AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD,…Official notice →
Other drugs & medical recalls in the United States
- 2021-10-20
- US
Roche Molecular Systems, Inc. recalls cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment
FDA · DeviceRoche Molecular Systems, Inc.Worldwide distribution - US Nationwide distribution and the countries of…Official notice → - US
Bio-Rad Laboratories, Inc. recalls BioPlex 2200 ANA Screen Control Set, REF: 663-1131 incompatible with ANA Screen Reagent Packs/ANA Kits, REF: 665-1150; and ANA Screen…
A new lot of ANA screen control and any subsequent control lots are incompatible with older lot numbers of ANA calibrators and ANA reagent packs.
FDA · DeviceBio-Rad Laboratories, Inc.Worldwide distribution - U.S Nationwide distribution including in the states…Official notice → - US
Philips North America LLC recalls Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A
Customers were not notified of previous recalls associated with various defibrillator models.
FDA · DevicePhilips North America LLCU.S.: CA, CT, FL, GA, IN, MI, MO, NJ, NY, OH, TX, and WA. International…Official notice → - US
National Distribution & Contracting Inc recalls ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser Btl
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.
FDA · DeviceNational Distribution & Contracting IncWorldwide distribution - US Nationwide distribution including in the states of…Official notice → - US
Abbott Molecular, Inc. recalls Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
There is a potential for false positive results.
FDA · DeviceAbbott Molecular, Inc.Worldwide Distribution. US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL,…Official notice → - US
Eli Lilly & Company recalls Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per vial; Diluent for Glucagon, 1 mL syringe. Rx only, Marketed…
SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also a lack of full drug effect upon administration.
FDA · DrugEli Lilly & CompanyNationwide with the USA and Puerto Rico; Canada, Argentina, Costa Rica, MexicoOfficial notice →