BEUDAMED
    FDA Recall Terminated

    Oxy Serve II Oxygen Conserving Regulator, Model Number: MCRB-870-6, Superior Products, Inc/SP Medical, LLC, Cleveland, Ohio 44144

    Recall: Z-0529-2008 · Initiated October 19, 2007

    Recall

    Recall Number
    Z-0529-2008
    Event Number
    45482
    Firm
    Superior Products Inc
    FEI Number
    1000515374
    Product Code
    NFB
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    October 19, 2007
    Posted
    January 23, 2008
    Terminated
    April 25, 2012
    Address
    3786 Ridge Rd, Cleveland, OH, 44144-1127

    Description

    Oxy Serve II Oxygen Conserving Regulator, Model Number: MCRB-870-6, Superior Products, Inc/SP Medical, LLC, Cleveland, Ohio 44144

    Reason

    Leakage: Device was leaking oxygen

    Action

    A Voluntary Medical Device Recall notification was delivered by certified mail on or about 10/19/2007, to all consignee's; "bill to" and "sent to." Consignee's are asked to contact their customers (if any), notify them of the recall, and return all implicated products to Superior Products.

    Distribution

    Worldwide-USA including states of CA, FL, IA, IN, KY, OH, SC, TX, and WA. and countries of Singapore, Mexico City, MX, and Turkey

    Quantity

    125