Reported Sep 11, 2024 · Ongoing
Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States:…
W L Gore & Associates, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: W L Gore & Associates, Inc. · 3750 W Kiltie Ln · Flagstaff, AZ · 86005-8712
Is this the product you have?
- Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis
- for the following Reference numbersUnited
- States
BXB051501ABXB051502ABXB051901ABXB051902ABXB052901ABXB052902ABXB053901ABXB053902ABXB055901ABXB055902ABXB057901ABXB057902ABXB061501ABXB061502ABXB061901ABXB061902ABXB062901ABXB062902ABXB063901ABXB063902ABXB065901ABXB065902ABXB067901ABXB067902ABXB071501ABXB071502ABXB071901ABXB071902ABXB072901ABXB072902ABXB073901ABXB073902ABXB075901ABXB075902ABXB077901ABXB077902ABXB082901ABXB082902ABXB083901ABXB083902ABXB085901ABXB085902ABXB087901ABXB087902ABXBL082901ABXBL082902ABXBL083901ABXBL083902ABXBL085901ABXBL085902ABXBL087901ABXBL087902ABXB092901ABXB092902ABXB093901ABXB093902ABXB095901A
- BXB095902A BXB097901A BXB097902A JapanBXB073901J BXB073902J BXB075901J BXB075902J BXB077901J BXB077902J
- Lot codes and dates
- Lot Serial Number/UDI
2,715 of 2,715 codes
278844300073313265825127884431007331326582512788443200733132658251278844330073313265825127884434007331326582512788443500733132658251278844360073313265825127884437007331326582512788443800733132658251278844390073313265825127884440007331326582512788444100733132658251278844420073313265825127884443007331326582512788444400733132658251278844450073313265825128325852007331326582512832585300733132658251283258540073313265825128325856007331326582512832585700733132658251284310710073313265825128431072007331326582512843107300733132658251285475580073313265825128547559007331326582512854756000733132658251286912060073313265825128691207007331326582512869120800733132658251
- Lot Serial Number/UDI
- Amount recalled
- 42,901 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Due to packaging defects, sterility assurance and heparin activity may be compromised.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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