BEUDAMED
    FDA Recall Terminated

    IRMA SL Blood Analysis System CC pH, pCO2, pO2, Hct, Na+, K+, iCa Cartridge, Part Number 039903(M3586A). There are 25 disposable cartridges in a box of IRMA SL Blood Analysis System CC pH, pCO2, pO2, Hct, Na+, K+, iCa Cartridges, Part Number 039903(M3586A).

    Recall: Z-1072-03 · Initiated July 14, 2003

    Recall

    Recall Number
    Z-1072-03
    Event Number
    26714
    Firm
    Diametrics Medical, Inc.
    FEI Number
    1000115726
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 14, 2003
    Posted
    July 30, 2003
    Terminated
    July 2, 2004
    Address
    2658 Patton Road, Roseville, MN, 55113

    Description

    IRMA SL Blood Analysis System CC pH, pCO2, pO2, Hct, Na+, K+, iCa Cartridge, Part Number 039903(M3586A). There are 25 disposable cartridges in a box of IRMA SL Blood Analysis System CC pH, pCO2, pO2, Hct, Na+, K+, iCa Cartridges, Part Number 039903(M3586A).

    Reason

    An incorrect lot designation, when entered into the blood analysis device, caused the device to give an error message and not operate.

    Action

    The consignees were notified of the recall by telephone on July 14, 2003 and requested to return the product.

    Distribution

    The product was shipped to 13 hospitals in California, Colorado, Florida, Iowa, Kansas, Minnesota, New Hamshire, Texas, and Wisconsin.

    Quantity

    103 boxes of 25 cartridges each.