Fusion Bioline Vascular Graft, Part number M00201503046B0
FDA device recall Z-1245-2023 · posted 2023-03-10 · Open, Classified
Recall details
- Recalling firm
- Maquet Cardiovascular, LLC
- 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.
- Action taken
- On January 30, 2023, the firm notified customers via Urgent Medical Device Removal letters. Customers are asked to examine your inventory immediately for lot 25162546. Please note, the Lot number appears on the device shelf boxes only. If you have the affected lot, please stop using and remove the device from areas of use. You are entitled to a replacement at no cost to your facility. You will receive replacement upon your acknowledgement that you have product for return. Distributors who have shipped this product should notify their customers. Please contact Getinge Customer Service at 888-943-8872 between the hours of 8:00 a.m. and 6:00 p.m. Eastern Standard Time to request a return authorization (RMA) and shipping instructions to return any affected product.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- DSY
- Quantity affected
- 1 (US)
- Distribution
- US Nationwide distribution in the states of FL, IN, LA, MI, MO, NC, NV, NY, PA, TN, TX, VA, WA.
- Date initiated
- 2023-01-30
- Date posted
- 2023-03-10
- Location
- Wayne, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT (K131778) | Maquet Cardiovascular, LLC | 2013-11-14 |