Heparin recall: Sterility Concern
Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB055902C, BXB063902C, BXB065902C…
Why was Heparin recalled?
Due to packaging defects, sterility assurance and heparin activity may be compromised.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Serial Number/UDI: 27342032/00733132658053; 27342035/00733132658053; 27342038/00733132658053; 27342047/00733132657926; 27342078/00733132657940; 27342079/00733132657940; 27342102/00733132657957; 27342104/00733132657957; 27342108/00733132657957; 27342253/00733132657964; 27342255/00733132657964; 27342256/00733132657964; 27342257/00733132657964; 27342258/00733132657964; 27342259/00733132657964; 27342260/00733132657964; 27342261/00733132657964; 27342262/00733132657964; 27342263/00733132657964; 27342264/00733132657971; 27342266/00733132657971; 27342267/00733132657971; 27342268/00733132657971; 27342269/00733132657971; 27342270/00733132657971; 27342290/00733132657988; 27342333/00733132657995; 27342334/00733132657995; 27342335/00733132657995; 27342336/00733132657995; 27342337/00733132657995; 27342338/00733132657995; 27342339/00733132657995; 27342340/00733132657995; 27342341/00733132657995; 27342342/00733132657995; 27342343/00733132657995; 27342344/00733132657995; 27342345/00733132657995; 27342346/00733132657995; 27342347/00733132657995; 27342349/00733132657995; 27342350/00733132657995; 27342352/00733132657995; 27342403/00733132658008; 27342535/00733132658015; 27342536/00733132658015; 27342571/00733132658022; 27342572/00733132658022; 27342585/00733132658039; 27342586/00733132658039; 27342587/00733132658039; 27342591/00733132658039; 27342624/00733132658046; 27342626/00733132658046; 27342627/00733132658046; 27342628/00733132658046; 27399807/00733132658053; 27399808/00733132658053; 27399814/00733132658053; 27399815/00733132658053; 27399816/00733132658053; 27399883/00733132657957; 27399884/00733132657957; 27399886/00733132657957; 27399894/00733132657964; 27399895/00733132657964; 27399896/00733132657964; 27399897/00733132657964; 27399898/00733132657964; 27399920/00733132657971; 27399921/00733132657971; 27399922/00733132657971; 27399923/00733132657971; 27399924/00733132657971; 27399925/00733132657971; 27399929/00733132657988; 27399933/00733132657988; 27399934/00733132657988; 27399935/00733132657988; 27399936/00733132657988; 27399937/00733132657988; 27399938/00733132657988; 27399939/00733132657988; 27399942/00733132657988; 27400054/00733132658015 27400056/ 00733132658015 27400073/ 00733132658022 27400077/ 00733132658039 27400078/ 00733132658039 27400079/ 00733132658039 27400084/ 00733132658039 27400085/ 00733132658039 27400103/ 00733132658046 27400104/ 00733132658046 27400105/ 00733132658046 27400110/ 00733132658046 27400111/ 00733132658046 27461768/ 00733132658046 27461769/ 00733132658046
- Product
- Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB055902C, BXB063902C, BXB065902C…
- Recalling firm
- W L Gore & Associates, Inc.
- Quantity
- 100 units
- Distribution
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the country of Japan.
- Recall date
- September 11, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)