BEUDAMED
    FDA Recall Terminated

    LifeShield Latex-Free 150 mL Burette Set, Nonvented, 117 Inch with Prepierced Injection Site, Backcheck Valve, 2 CLAVE Ports and Removable 4-Way High Flow Stopcock Microdrip Soluset; Product 19292; Made in Costa Rica, Abbott Laboratories, North Chicago, IL 60064

    Recall: Z-0914-03 · Initiated May 13, 2003

    Recall

    Recall Number
    Z-0914-03
    Event Number
    26343
    Firm
    Abbott Laboratories HPD/ADD
    FEI Number
    1415939
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 13, 2003
    Posted
    June 5, 2003
    Terminated
    November 20, 2003
    Address
    100/200 Abbott Park Road, Abbott Park, IL, 60064

    Description

    LifeShield Latex-Free 150 mL Burette Set, Nonvented, 117 Inch with Prepierced Injection Site, Backcheck Valve, 2 CLAVE Ports and Removable 4-Way High Flow Stopcock Microdrip Soluset; Product 19292; Made in Costa Rica, Abbott Laboratories, North Chicago, IL 60064

    Reason

    IV Burette administration sets are mislabeled as having pre-pierced injection sites, when the injection sites are not pre-pierced.

    Action

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

    Distribution

    Nationwide. California, Colorado, Connecticut, Georgia, Illinois, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Montana, New Hampshire, New Jersey, New York, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington and Wisconsin.

    Quantity

    7,160 units