BEUDAMED
    FDA Recall Terminated

    MedGraphics Cardiorespiratory Diagnostic Systems Pulmonary Function Gas, For Diagnostic Use Only, Part No. 536053-009, Reference Gas, containing Oxygen 21% plus/minus 0.02% Absolute, and Nitrogen: Balance., ED cylinder size. The label shows Manufactured for: Medical Graphics Corporation, St. Paul, MN, as the responsible firm.

    Recall: Z-0317-04 · Initiated December 2, 2003

    Recall

    Recall Number
    Z-0317-04
    Event Number
    27796
    Firm
    Puritan Medical Products Inc
    FEI Number
    1912755
    Product Code
    BXH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 2, 2003
    Posted
    July 20, 2004
    Terminated
    November 23, 2004
    Address
    9101 Bond St, Overland Park, KS, 66214-1726

    Description

    MedGraphics Cardiorespiratory Diagnostic Systems Pulmonary Function Gas, For Diagnostic Use Only, Part No. 536053-009, Reference Gas, containing Oxygen 21% plus/minus 0.02% Absolute, and Nitrogen: Balance., ED cylinder size. The label shows Manufactured for: Medical Graphics Corporation, St. Paul, MN, as the responsible firm.

    Reason

    Oxygen component is out of specification

    Action

    Phone calls were initiated 12/2/03 requesting return of the recalled cylinders. Registered letters dated 12/9/03 were issued as a follow-up to the phone call.

    Distribution

    Distribution was made to medical facilities located in nationwide.

    Quantity

    60 cylinders