BEUDAMED
    FDA Recall Terminated

    Electrode, VaporCut, 24FR (27050SG/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).

    Recall: Z-1312-2013 · Initiated June 1, 2009

    Recall

    Recall Number
    Z-1312-2013
    Event Number
    55358
    Firm
    Karl Storz Endoscopy America Inc
    FEI Number
    2020550
    Product Code
    FJL
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    June 1, 2009
    Posted
    May 11, 2013
    Terminated
    May 13, 2013
    Address
    2151 East Grand Avenue, El Segundo, CA, 90245

    Description

    Electrode, VaporCut, 24FR (27050SG/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).

    Reason

    Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.

    Action

    A Safety Alert dated May 29, 2009 was sent to affected customers. The letter informed them of possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products which may result in airborne contamination. Karl Storz requested consignees to inspect their inventory of the subject products thoroughly and look for small holes in the blister trays. Any identified units should be returned to Karl Storz, and a replacement package (6 units per package) will be provided to at no charge. The Karl Storz Customer Support number 1-800-421-0837 ext. 7577 was provided to obtain a Return Authorization Number (RMA) and arrange replacement. Questions and comments were forwarded to Technical Support at 1-800-421-0837 ext. 5350.

    Distribution

    Distributed Nationwide and in Canada.

    Quantity

    9432 units