BEUDAMED
    FDA Recall Terminated

    Jackson-Pratt Reservoir, 400 mL suction reservoir; a sterile, single use only, Rx device used as a component of the wound drain system, individually packaged, 10 reservoirs per case; catalog #SU130-1000; Allegiance Healthcare Corporation, McGaw Park, IL 60085 USA

    Recall: Z-1407-04 · Initiated July 28, 2004

    Recall

    Recall Number
    Z-1407-04
    Event Number
    29739
    Firm
    Cardinal Health
    FEI Number
    3001236905
    Product Code
    GBX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 28, 2004
    Posted
    August 25, 2004
    Terminated
    February 10, 2005
    Address
    1430 Waukegan Rd, McGaw Park, IL, 60085

    Description

    Jackson-Pratt Reservoir, 400 mL suction reservoir; a sterile, single use only, Rx device used as a component of the wound drain system, individually packaged, 10 reservoirs per case; catalog #SU130-1000; Allegiance Healthcare Corporation, McGaw Park, IL 60085 USA

    Reason

    The products labeled as sterile are not sterile.

    Action

    The accounts were telephoned on 7/28/04 and sent follow-up letters on the same date. They were informed that affected lots of products were not sterile, and were requested to inspect their inventory and segregate the product for return to Cardinal Health. The accounts were instructed to call 800-635-6021 for product return and instructions on how to obtain credit and replacement product.

    Distribution

    Florida, Arizona, New Jersey and Canada

    Quantity

    60 cases