BEUDAMED
    FDA Recall Terminated

    Abbott Latex-Free Primary I.V. Plumset Convertible Pin, 95 inch with Injection Site and Secure Lock, No. 19020; Made in Costa Rica, Abbott Laboratories, North Chicago, IL 60064

    Recall: Z-0936-03 · Initiated May 13, 2003

    Recall

    Recall Number
    Z-0936-03
    Event Number
    26349
    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

    Abbott Latex-Free Primary I.V. Plumset Convertible Pin, 95 inch with Injection Site and Secure Lock, No. 19020; Made in Costa Rica, Abbott Laboratories, North Chicago, IL 60064

    Reason

    The I.V. administration set incorrectly lists the priming volume from the cassette inlet to distal male adapter as 13.5 mL instead of 11.3 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

    Miami, FL

    Quantity

    4,656 units