Reported Oct 20, 2021 · Ongoing
Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON…
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 ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent Diameter 8 mm, Max Post-Dilated Stent Diameter 16 mm
- UDI—
- Lot codes and dates
- Serial Numbers22753580
- Amount recalled
- 2 units
Why it was recalled
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.
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.
Free recall alerts
Get alerted about new W L Gore & Associates, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.