BEUDAMED
    FDA Recall Terminated

    VariSource AL 13199024, Implant Tube, Implant Tube, Intralumenal(HDR), 10CM Drawdown 130CM Body, Sealed End, Cable Insert & Gold Seed, Disposable

    Recall: Z-0816-06 · Initiated February 21, 2006

    Recall

    Recall Number
    Z-0816-06
    Event Number
    34969
    Firm
    Alpha Omega Services Inc
    FEI Number
    2022694
    Product Code
    JAQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 21, 2006
    Posted
    April 27, 2006
    Terminated
    August 30, 2006
    Address
    9156 Rose St, Bellflower, CA, 90706

    Description

    VariSource AL 13199024, Implant Tube, Implant Tube, Intralumenal(HDR), 10CM Drawdown 130CM Body, Sealed End, Cable Insert & Gold Seed, Disposable

    Reason

    There is a possibility that the diameter of the catheter does not meet specifications. As a result it may not be possible to correctly connect the catheter to a VariSource Quick Connect. This would prevent any treatment. Furthermore, since the problem would not be apparent until after the catheter has been implanted an unnecessary surgical implantation procedure would have taken place.

    Action

    Recall Notification Letter: began February 22, 2006. Depth/Scope: 100% of the customer''s who purchased the affected products will be identified and contacted with a faxed and mailed Medical Device Recall notice and followed up with a phone call by the AOS Sales & Marketing personnel. All customers will be requested return all affected products, both used and unused.

    Distribution

    Nationwide and Argentina, Brasil, Canada, Israel, Korea, , Taiwan, United Kingdom & Venezuela

    Quantity

    24