BEUDAMED
    FDA Recall Terminated

    Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc., 3135 Quarry Road, Telford, PA 18969.

    Recall: Z-0018-2011 · Initiated August 19, 2010

    Recall

    Recall Number
    Z-0018-2011
    Event Number
    56600
    Firm
    Draeger Medical Systems, Inc.
    FEI Number
    2510954
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    August 19, 2010
    Posted
    October 7, 2010
    Terminated
    November 18, 2010
    Address
    3135 Quarry Rd, Telford, PA, 18969-1042

    Description

    Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc., 3135 Quarry Road, Telford, PA 18969.

    Reason

    Patients received insufficient ventilation. The Oxylog 3000 Instructions are inadequate relating to dead space volume.

    Action

    The firm sent Important Safety Notice Letter, dated August 2010, and Instructions for Use supplement to consignees. The letter explained the issue with the affected product. The letter asks customers to attach the Instructions for Use amendment sheet supplied with the letter to their corresponding Instructions for Use. The firm also states that a they will provide a dedicated pediatric breathing circuit for the Oxylog 3000. Questions regarding the letter should be directed to Michael Kelhart at 1-800-543-5047. Questions regarding the use of the device should be directed to DragerService Technical Support at 1-800-543-5047 or your local Drager Sales Representative.

    Distribution

    Nationwide Distribution

    Quantity

    78 potentially afftected units