BEUDAMED
    FDA Enforcement Class I Terminated

    AlboGraft Knitted with Collagen, Straight 40x08 Catalog Number: AMC4008 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.

    Recall: Z-1761-2013 · Reported July 31, 2013

    Enforcement

    Recall Number
    Z-1761-2013
    Event ID
    65553
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    LeMaitre Vascular, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 31, 2013
    Initiation Date
    June 17, 2013
    Classification Date
    July 22, 2013
    Termination Date
    August 15, 2016
    Address
    63 2nd Ave, N/A, Burlington, MA, 01803-4413, United States

    Description

    AlboGraft Knitted with Collagen, Straight 40x08 Catalog Number: AMC4008 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.

    Reason

    Blood blushing/leaking from the surface of the graft after implantation

    Code Info

    Lot number/Expiration Date 56890A 2015-04

    Distribution

    Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.

    Quantity

    3 units