BEUDAMED
    FDA Enforcement Class II Terminated

    Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, PINK/RED Oxygen Delivery Module 2/PACK, Product Code 7700RAW2

    Recall: Z-2846-2016 · Reported September 28, 2016

    Enforcement

    Recall Number
    Z-2846-2016
    Event ID
    74647
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Carefusion 2200 Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 28, 2016
    Initiation Date
    June 29, 2016
    Classification Date
    September 20, 2016
    Termination Date
    March 2, 2018
    Address
    75 N Fairway Dr, Vernon Hills, IL, 60061-1845, United States

    Description

    Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, PINK/RED Oxygen Delivery Module 2/PACK, Product Code 7700RAW2

    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.

    Code Info

    Lot numbers 914873, 914876, and 914878 of the individual modules (7700RAW), which are contained in Lot number 914867 of the 2/PACK (7700RAW2). Expiration Date JAN 2021.

    Distribution

    Illinois

    Quantity

    544 (2/PACKS)