BEUDAMED
    FDA Recall Terminated

    Western Medica OPC Portable Oxygen Conserving Regulator, Model MDL-7609, 1/2 - 5 LPM, packaged under the Medline label.

    Recall: Z-0056-04 · Initiated October 2, 2003

    Recall

    Recall Number
    Z-0056-04
    Event Number
    27188
    Firm
    Western a Scott Fetzer Co
    FEI Number
    1526809
    Product Code
    BZD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 2, 2003
    Posted
    October 24, 2003
    Terminated
    January 6, 2006
    Address
    875 Bassett Rd, Westlake, OH, 44145

    Description

    Western Medica OPC Portable Oxygen Conserving Regulator, Model MDL-7609, 1/2 - 5 LPM, packaged under the Medline label.

    Reason

    The demand valve is defective and does not function as intended in the 'Conservative Mode'.

    Action

    The firm notified the affected consignees by letter on 10/2/2003. Customers were asked to return the units for replacements.

    Distribution

    The device was distributed nationwide and into China and Japan.

    Quantity

    1,106 units