BEUDAMED
    FDA Recall Terminated

    Cleaning probe included as an accessory to aspirators that are sterile packed single use disposable accessories to the GE InstaTrak 3500 Plus x-ray system. Probes are packaged and shipped together with the following aspirators: Straight Aspirator - 1000370-NAV, 7 French Aspirator - 100936, Keane - Moses Extended Straight Aspirator - 1000748, 15 degree aspirator - 1003895, Fried 45 Degree Aspirator - 1000541, Kuhn 90 degree Aspirator - 1000543-NAV.

    Recall: Z-1130-2007 · Initiated May 18, 2007

    Recall

    Recall Number
    Z-1130-2007
    Event Number
    38373
    Firm
    GE OEC Medical Systems, Inc
    FEI Number
    1720753
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 18, 2007
    Posted
    August 7, 2007
    Terminated
    August 22, 2011
    Address
    384 Wright Brothers Dr, Salt Lake City, UT, 84116-2862

    Description

    Cleaning probe included as an accessory to aspirators that are sterile packed single use disposable accessories to the GE InstaTrak 3500 Plus x-ray system. Probes are packaged and shipped together with the following aspirators: Straight Aspirator - 1000370-NAV, 7 French Aspirator - 100936, Keane - Moses Extended Straight Aspirator - 1000748, 15 degree aspirator - 1003895, Fried 45 Degree Aspirator - 1000541, Kuhn 90 degree Aspirator - 1000543-NAV.

    Reason

    Cleaning probes used to unclog disposable aspirators may shed small particles of nylon material which may be transferred into the nasal cavity.

    Action

    Consignees were notified by certified mail on 05/18/2007 and were told to stop using and to dispose of the affected probes.

    Distribution

    Worldwide, including USA, Canada and France.

    Quantity

    67,625 units