AlboGraft Woven with Collagen, Straight 30x16 Catalog Number: ATC3016 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
- Company
- Lemaitre Vascular, Inc.
- Recall Initiated
- June 17, 2013
- Posted
- July 22, 2013
- Terminated
- August 15, 2016
- Recall Number
- Z-1767-2013
- Quantity
- 1 unit
- Firm Location
- Burlington, MA
Reason for Recall
Blood blushing/leaking from the surface of the graft after implantation
Distribution
Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.
Lot / Code Info
Lot number/Expiration Date 56890A 2015-04
Root Cause
Process control
Action Taken
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.