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U.S. Department of Health and Human Services

Class 1 Device Recall LeMaitre Albograft

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 Class 1 Recall
LeMaitre Albograft
see related information
Date Posted July 22, 2013
Recall Status1 Open
Recall Number Z-1764-2013
Recall Event ID 65553
Premarket Notification
510(K) Numbers
K093231  K103080 
Product Classification Graft, Vascular, Synthetic/Biologic Composite - Product Code MAL
Product AlboGraft Knitted with Collagen, Straight 60x08 Catalog Number: AMC6008 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Code Information Lot number/Expiration Date 56890A 2015-04
Recalling Firm/
Manufacturer
LeMaitre Vascular, Inc.
63 2nd Ave
Burlington, Massachusetts 01803-4413
For Additional Information Contact Laurie Churchill
781-425-1670 Ext. 108
Manufacturer Reason
for Recall
Blood blushing/leaking from the surface of the graft after implantation
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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 in Commerce 2 units
Distribution Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MAL and Original Applicant = LEMAITRE VASCULAR, INC.
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