Recall Z-1762-2013 ยท MAL Graft, Vascular, Synthetic/Biologic Composite
LeMaitre Vascular, Inc.
AlboGraft Knitted with Collagen, Straight 60x06 Catalog Number: AMC6006 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
| Date | Jul 22, 2013 (initiated Jun 17, 2013) |
| Status | Terminated |
| Reason | Blood blushing/leaking from the surface of the graft after implantation |
| Root cause | Process control |
| Action | LeMaitre Vascular, Inc.sent an Urgent Field Safety Notice daed June 19, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify and return the affected device to MeMaitre Vascular which they will replace with a new unit. Customers with questions were instructed to call 781-221-2266, ext. 183. For questions regarding this recall call 781-425-1670, ext 108. |
| Quantity | 3 units |
| Distribution | Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY. |
| FDA record | Open on fda.gov |