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.
Reason for recall: 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. Distribution: US Nationwide distribution in the states of FL, IN, LA, MI, MO, NC, NV, NY, PA, TN, TX, VA, WA. Quantity: 1 (US) Lot/code info: UDI-DI 00384409005942 Lot 25162546
00384409005942
Official record: FDA (Device enforcement) ↗
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