BEUDAMED
    FDA Recall Terminated

    Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, Broselow Complete Set of Colored Pouches, Product Code 7730MOD

    Recall: Z-2847-2016 · Initiated June 29, 2016

    Recall

    Recall Number
    Z-2847-2016
    Event Number
    74647
    Firm
    Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845
    FEI Number
    3008002452
    Product Code
    CAE
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    June 29, 2016
    Terminated
    March 2, 2018

    Description

    Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, Broselow Complete Set of Colored Pouches, Product Code 7730MOD

    Reason

    The Oral Airway pouch within the PINK/RED Oxygen Delivery Module, 7700RAW, was incorrectly packaged with the 8 cm Berman Oral Airway. The pouch contained within the module is correctly labeled as 5 cm but actually contains an 8 cm Berman Oral Airway component. Therefore, the component within the pouch is incorrect. The PINK/RED Oxygen Delivery Module, 7700RAW, is intended to be used within the PINK/RED Pouch of the BROSELOW pediatric safety system. Three (3) lots (lot# 914873, lot# 914876 and lot #914878) of the PINK/RED Oxygen Delivery Module, 7700RAW, are affected by this voluntary Field Safety Corrective Action.

    Action

    Recall notices were sent 6/29/2016.

    Distribution

    Illinois

    Quantity

    50 units