Z-1245-2023 Class II Ongoing
FDA device recall Z-1245-2023 was initiated by Maquet Cardiovascular, LLC on January 30, 2023 and is designated Class II. 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 res… The recall status is ongoing. Affected quantity: 1 (US).
Recall Details
- Product Type
- Devices
- Report Date
- March 22, 2023
- Initiation Date
- January 30, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 (US)
Product Description
Fusion Bioline Vascular Graft, Part number M00201503046B0
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 Pattern
US Nationwide distribution in the states of FL, IN, LA, MI, MO, NC, NV, NY, PA, TN, TX, VA, WA.
Code Information
UDI-DI 00384409005942 Lot 25162546