BEUDAMED
    FDA Recall Terminated

    Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 24 Fr., 4.0 cm length, Item Number: 55723.

    Recall: Z-0702-04 · Initiated March 1, 2004

    Recall

    Recall Number
    Z-0702-04
    Event Number
    28421
    Firm
    Ross Products Division Abbott Laboratories
    FEI Number
    1000136098
    Product Code
    KNT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 1, 2004
    Posted
    July 20, 2004
    Terminated
    October 24, 2008
    Address
    625 Cleveland Ave, Columbus, OH, 43215-1754

    Description

    Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 24 Fr., 4.0 cm length, Item Number: 55723.

    Reason

    The balloons may be defective as indicated by an increased number of early balloon failures, which may result in tube displacement from patient.

    Action

    The firm notified their customers on 3/1/2004 by telephone, fax, and FedEx. Product will be returned.

    Distribution

    Nationwide; Australia, New Zealand, Italy.