BEUDAMED
    FDA Recall Terminated

    ACMI REF E-1F Electrohydraulic Lithotripsy Probe, 1.9 FR x 120CM

    Recall: Z-0925-04 · Initiated April 30, 2004

    Recall

    Recall Number
    Z-0925-04
    Event Number
    28975
    Firm
    ACMI CORPORATION
    Product Code
    FFK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 30, 2004
    Posted
    July 20, 2004
    Terminated
    June 13, 2005
    Address
    136 Turnpike Road, Southborough, MA, 01772

    Description

    ACMI REF E-1F Electrohydraulic Lithotripsy Probe, 1.9 FR x 120CM

    Reason

    Product sterility may be compromised due to the lack of package seal integrity

    Action

    ACMI issued a recall letter dated 4/30/04 via Certified Mail. Users will be asked to return unused product. International Distributors were faxed letters notifying of them of the action.

    Distribution

    Nationwide Foreign: Canada, Australa, Brazil, Korea, Mexico, Turkey

    Quantity

    1479 boxes (3 probes/box)