BEUDAMED
    FDA Recall Terminated

    Smiths Medical FLO2 Emergency Non-rebreather High Flow O2 System; Positive end expiratory pressure breathing attachment; Reference Number: P60000; Smiths Medical, Rockland, MA 02370.

    Recall: Z-1379-2008 · Initiated March 4, 2008

    Recall

    Recall Number
    Z-1379-2008
    Event Number
    46947
    Firm
    Smiths Medical ASD, Inc.
    FEI Number
    1221261
    Product Code
    BYE
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 4, 2008
    Posted
    July 16, 2008
    Terminated
    August 20, 2012
    Address
    160 Weymouth St, Rockland, MA, 02370-1136

    Description

    Smiths Medical FLO2 Emergency Non-rebreather High Flow O2 System; Positive end expiratory pressure breathing attachment; Reference Number: P60000; Smiths Medical, Rockland, MA 02370.

    Reason

    Incorrect Oxygen Level: Device may not provide expected oxygen concentration or the expected flow rate due to incorrectly molded part. Patient will not receive proper amounts of air/oxygen when in need.

    Action

    Consignees were notified on 2/26/08 via telephone to place the affected products on hold pending further instruction from the recalling firm. A follow-up letter was issued on 3/4/08 advising consignees to return any product in stock for a replacement or credit. Distributors were requested to provide their customer lists to the recalling firm in order to notify their customers of this recall.

    Distribution

    Worldwide Distribution including USA states of CA, FL, IN, KS, MN, MO, NC, NH, NY, PA and TN, and country of Canada.

    Quantity

    650