Reported Mar 22, 2023 · Ongoing
Fusion Bioline Vascular Graft, Part number M00201503046B0
Maquet Cardiovascular, LLC
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: Maquet Cardiovascular, LLC · 45 Barbour Pond Dr · Wayne, NJ · 07470-2094
Is this the product you have?
- Fusion Bioline Vascular Graft, Part number M00201503046B0
- Lot codes and dates
- UDI-DI 00384409005942 Lot 25162546
- Amount recalled
- 1 (US)
Where it was sold
Why it was recalled
One (1) Fusion Bioline Vascular graft from lot 25162546, which failed guideline straightness testing, was intermingled with lot 25162549 and distributed to customers. Use of the affected graft may result in reduction of blood flow or unwanted tension causing bleeding and the formation of a pseudo-aneurysm.
This product could cause temporary or reversible health problems — stop using it.
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