BEUDAMED
    FDA Recall Terminated

    Angio-Seal Vascular Closure Device. Ref 610109. 6F STS Platform. Sterilized by gamma radiation. For single use only. St. Jude Medical, Daig Division, Inc., Minnetonka, MN 55345-2126, USA.

    Recall: Z-0677-06 · Initiated August 22, 2005

    Recall

    Recall Number
    Z-0677-06
    Event Number
    33329
    Firm
    St. Jude Medical Daig Division
    FEI Number
    2182269
    Product Code
    MGB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 22, 2005
    Posted
    March 25, 2006
    Terminated
    July 22, 2006
    Address
    14901 Deveau Pl, Minnetonka, MN, 55345-2126

    Description

    Angio-Seal Vascular Closure Device. Ref 610109. 6F STS Platform. Sterilized by gamma radiation. For single use only. St. Jude Medical, Daig Division, Inc., Minnetonka, MN 55345-2126, USA.

    Reason

    Mispackaging-Some Angio-Seal 6F STS Vascular Closure Devices from Lot no. 1146548 have been incorrectly packaged with a 0.035' guidewire instead of a 0.032' guidewire.

    Action

    Letters were delivered to the hospitals and/or doctors in possession of the product instructing them to return it.

    Distribution

    International Only-Belgium, China, Guadalajara, New Zealand and Thailand.

    Quantity

    4160