BEUDAMED
    FDA Recall Terminated

    Stellant Dual Syringe Kits. CT Injector and Accessories. Catalog Number SDS-CTP-QFT and SDS-CTP-SPK.

    Recall: Z-0257-05 · Initiated November 3, 2004

    Recall

    Recall Number
    Z-0257-05
    Event Number
    30432
    Firm
    Medrad Inc
    FEI Number
    2520313
    Product Code
    DXT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 3, 2004
    Posted
    November 24, 2004
    Terminated
    April 20, 2005
    Address
    1 Medrad Dr, Indianola, PA, 15051-9759

    Description

    Stellant Dual Syringe Kits. CT Injector and Accessories. Catalog Number SDS-CTP-QFT and SDS-CTP-SPK.

    Reason

    Sterility can be compromised by a tear in the outer packaging.

    Action

    The recalling firm issued recall letters dated 11/1/04 to their consignees informing them of the problem and the need to return the product.

    Distribution

    The product was shipped to distributors and medical facilities nationwide. The product was also shipped to Saudia Arabia, Kuwaitt, Maylasia, Israel, Chile, Hong Kong, Great Britain, Denmark, Germany, China, Canada, France, Taiwan, Thailand, Singapore, Finland, Phillipines, Norway, Netherlands,, Spain, Mexico, Czech, Japan, Italy, Sweden, Brazil, Belgium, and Austraila.

    Quantity

    875, 798 kits