BEUDAMED
    FDA Recall Terminated

    Microstream SMART CAPNOLINE PLUS O2 LONG 100 UN Part Number: 010341 010341 Part Number: 10341

    Recall: Z-2013-2010 · Initiated May 26, 2010

    Recall

    Recall Number
    Z-2013-2010
    Event Number
    55790
    Firm
    Oridion Medical
    FEI Number
    3001227743
    Product Code
    cck
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    May 26, 2010
    Posted
    July 13, 2010
    Terminated
    June 21, 2012
    Address
    1987 Ltd. 7 Hamarpe St. P.O. Box 45025, Har Hotzvim Industrial Park Jerusalem Israel

    Description

    Microstream SMART CAPNOLINE PLUS O2 LONG 100 UN Part Number: 010341 010341 Part Number: 10341

    Reason

    The Microstream Filterline may not be recognized by the monitor when connected. No CO2 readings will be displayed and no alarms may sound for unmonitored patients. Replacing the filterline may delay treatment.

    Action

    Oridion notified customers by letter on 5/26/10 and requested that they remove the FilterLines from the related production lots from the field and an immediate replacement with FilterLines from subsequent production lots. Questions are directed to the responsible person at the supplier named in the letter, or to Oridion Capnography at 888-674-3466.

    Distribution

    AZ, CA, FL, HI, LA, , MA, MO, NJ, OH, PA, WA, WI,

    Quantity

    153,000 units (153 boxes/100 units)