BEUDAMED
    FDA Recall Terminated

    Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories. Catalog number SSS-CTP-QFT

    Recall: Z-0039-05 · Initiated October 8, 2004

    Recall

    Recall Number
    Z-0039-05
    Event Number
    30240
    Firm
    Medrad Inc
    FEI Number
    2520313
    Product Code
    DXT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 8, 2004
    Posted
    October 22, 2004
    Terminated
    January 25, 2005
    Address
    1 Medrad Dr, Indianola, PA, 15051-9759

    Description

    Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories. Catalog number SSS-CTP-QFT

    Reason

    Sterility can be compromised by a component tearing the outer packaging

    Action

    The recalling firm telephoned their customers on 10/8/04 to inform them of the problem and the need to return the product.

    Distribution

    The product was shipped to medical facilities in AR, CA, CO, FL, LA, MI, NJ, NY, PA, and TX.

    Quantity

    1650 kits