BEUDAMED
    FDA Recall Terminated

    Medline EndurO2 Oxygen Concentrator with Oxygen Monitor; Portable oxygen generator; Reorder Number: HCS02; Packaged in 1 unit per case; Product is an oxygen generator designed to provide oxygen to patient who has been prescribed oxygen therapy by a physician.

    Recall: Z-1473-2008 · Initiated March 4, 2008

    Recall

    Recall Number
    Z-1473-2008
    Event Number
    47225
    Firm
    Medline Industries Inc
    FEI Number
    1417592
    Product Code
    CAW
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 4, 2008
    Posted
    July 23, 2008
    Terminated
    June 17, 2010
    Address
    1 Medline Pl, Mundelein, IL, 60060-4486

    Description

    Medline EndurO2 Oxygen Concentrator with Oxygen Monitor; Portable oxygen generator; Reorder Number: HCS02; Packaged in 1 unit per case; Product is an oxygen generator designed to provide oxygen to patient who has been prescribed oxygen therapy by a physician.

    Reason

    Overheating of Components: There is the potential for an electrical component in the oxygen concentrator to overheat, causing damage to the unit and making it nonfunctional.

    Action

    Consignees were notified by a letter sent on 3/4/08. The letter informed users that the recalling firm will replace the affected units with new units or issue a credit for the returned recalled units. Distributors were requested to notify their accounts of the recall. The letter requested users to complete and return an enclosed response sheet, indicating the number of units to be replaced or returned for credit. For additional information, contact 866-359-1704.

    Distribution

    Nationwide Distribution