Fusion Bioline Vascular Graft recall
Fusion Bioline Vascular Graft, Part number M00201503046B0
Why was Fusion Bioline Vascular Graft 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI 00384409005942 Lot 25162546
- Product
- Fusion Bioline Vascular Graft, Part number M00201503046B0
- Recalling firm
- Maquet Cardiovascular, LLC
- Quantity
- 1 (US)
- Distribution
- US Nationwide distribution in the states of FL, IN, LA, MI, MO, NC, NV, NY, PA, TN, TX, VA, WA.
- Recall date
- March 22, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)