BEUDAMED
    FDA Recall Terminated

    T-U-R Y-Set Non-Vented Set for Transurethral Resection Procedures For Use with Flexible Irrigation Container System, 84 inch (213 cm) Nominal Length, No. 15252-02; Made in Costa Rica, Abbott Laboratories, North Chicago, IL 60064

    Recall: Z-0934-03 · Initiated May 13, 2003

    Recall

    Recall Number
    Z-0934-03
    Event Number
    26348
    Firm
    Abbott Laboratories HPD/ADD
    FEI Number
    1415939
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 13, 2003
    Posted
    June 17, 2003
    Terminated
    November 20, 2003
    Address
    100/200 Abbott Park Road, Abbott Park, IL, 60064

    Description

    T-U-R Y-Set Non-Vented Set for Transurethral Resection Procedures For Use with Flexible Irrigation Container System, 84 inch (213 cm) Nominal Length, No. 15252-02; Made in Costa Rica, Abbott Laboratories, North Chicago, IL 60064

    Reason

    The irrigation set was mislabeled with the wrong delivery rate of 8 drops/mL when it actually has a delivery rate of 11 drops/mL

    Action

    Recall letter dated 5/12/03 sent to the account on 5/13/03, informing them of the labeling discrepancy and requesting the return of any inventory of the affected lot to Abbott for credit.

    Distribution

    New Orleans, LA

    Quantity

    60 units