FDA-Device2023-03-22Class II
Fusion Bioline Vascular Graft, Part number M00201503046B0
Maquet Cardiovascular, LLC
Hazard
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.
Sold states
US Nationwide distribution in the states of FL, IN, LA, MI, MO, NC, NV, NY, PA, TN, TX, VA, WA.
Affected count
1 (US)
Manufactured in
45 Barbour Pond Dr, N/A, Wayne, NJ, United States
Products
Fusion Bioline Vascular Graft, Part number M00201503046B0
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1245-2023Don't want to check this manually?
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