BEUDAMED
    FDA Recall Terminated

    Guidewire, 70cm x 1mm, REF 5583705, Sterile, Single Use, BARD Access Systems, Hemodialysis Catheter, Salt Lake City, UT 84116.

    Recall: Z-1229-2007 · Initiated August 10, 2007

    Recall

    Recall Number
    Z-1229-2007
    Event Number
    38621
    Firm
    C.R. Bard Access Systems, Inc
    FEI Number
    3006260740
    Product Code
    MPB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 10, 2007
    Posted
    September 20, 2007
    Terminated
    April 25, 2008
    Address
    5425 Amelia Earhart Dr, Salt Lake City, UT, 84116-3713

    Description

    Guidewire, 70cm x 1mm, REF 5583705, Sterile, Single Use, BARD Access Systems, Hemodialysis Catheter, Salt Lake City, UT 84116.

    Reason

    Metal guidewires used in Hemodialysis Catheters may have been reverse loaded within the dispenser. Potential exists for the stiff end of the guidewire to be inserted into the patient instead of the flexible end.

    Action

    Consignees were notified by letter on 08/10/2007 and asked to remove and return all unused affected product to Bard.

    Distribution

    Worldwide, including USA, Canada, Latin America, and Europe (Austria, Belgium, Finland, France, Germany, Great Britain, Holland, Italy, Norway, Spain, and Sweden).

    Quantity

    7225 units