BEUDAMED
    FDA Recall Terminated

    535D-X CF Continuous Flow Cylinder

    Recall: Z-0732-2007 · Initiated January 24, 2007

    Recall

    Recall Number
    Z-0732-2007
    Event Number
    37189
    Firm
    Sunrise Medical
    FEI Number
    2515872
    Product Code
    NFB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 24, 2007
    Posted
    April 21, 2007
    Terminated
    August 27, 2009
    Address
    100 Devilbiss Dr, Somerset, PA, 15501-2125

    Description

    535D-X CF Continuous Flow Cylinder

    Reason

    Cylinder could lose oxygen at high pressure after the filling process

    Action

    The recalling firm began to notify customer via telephone on 1/24/07. An ''Urgent Medical Device Recall Letter'' was sent on 1/29/07. Customers were advised what model and serial numbers were affected and how to contact the firm and/or dealer to have the unit replaced. The recalling firm identified additional serial numbers that were involved in the recall therefore another Urgent Medical Device Recall Letter dated 6/12/07 was sent to the customers that received the addiitonal units.

    Distribution

    Worldwide-original shipments to distributors/dealers USA and Canada.

    Quantity

    4,169 units (Z-0731/0732-2007)