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U.S. Department of Health and Human Services

Enforcement Report - Week of July 31, 2013

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Product Detail

Product Description AlboGraft Woven with Collagen, Straight 30x18 Catalog Number: ATC3018 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Recall Number Z-1768-2013
Classification Class I
Code Info Lot number/Expiration Date 56890A 2015-04
Product Distributed Qty 1 unit
Reason For Recall Blood blushing/leaking from the surface of the graft after implantation

Event Detail

Event Id 65553
Product Type Devices
Status Ongoing
Recalling Firm LeMaitre Vascular, Inc.
City Burlington
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-17
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.