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
BXB055902CBXB063902CBXB065902CBXB067902CBXB073902CBXB075902CBXB077902CBXB083902CBXB085902CBXB087902CBXB093902CBXB095902CBXB097902C *For Clinical use
- Lot codes and dates
86 of 86 products · 86 lot codes
Recalled lot codes, grouped by product number Lot Serial Number UDI 2734203200733132658053
2734203500733132658053
2734203800733132658053
2734204700733132657926
2734207800733132657940
2734207900733132657940
2734210200733132657957
2734210400733132657957
2734210800733132657957
2734225300733132657964
- Amount recalled
- 100 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.
Want the full recall guide?
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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