BEUDAMED
    FDA Recall Terminated

    BG cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 048103. BG Cartridge are single use, disposable, in vitro diagnostics intended for point of care (POC), professional, use with the IRMA TRUpoint Blood Analysis System.

    Recall: Z-0160-2016 · Initiated September 16, 2015

    Recall

    Recall Number
    Z-0160-2016
    Event Number
    72305
    Firm
    LifeHealth, LLC
    FEI Number
    1000115726
    Product Code
    CHL
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 16, 2015
    Posted
    October 23, 2015
    Terminated
    March 21, 2016
    Address
    2656 Patton Rd, Roseville, MN, 55113-1136

    Description

    BG cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 048103. BG Cartridge are single use, disposable, in vitro diagnostics intended for point of care (POC), professional, use with the IRMA TRUpoint Blood Analysis System.

    Reason

    May report values outside the published performance specifications for pH. After a certain point in shelf life, the pH sensor may give results that are falsely elevated. The discrepancy is greater as shelf life progresses and can be seen on the aqueous controls before the blood.

    Action

    Consignees were sent a LifeHealth "Urgent Medical Device Recall" letter dated September 16, 2015. The letter described the problem and the product involved in the recall. The letter described the Risk to Health, Action to be taken and Other Information. Consignees were advised to discontinue use and destroy all stock on hand. Requested consignees to complete and return the Verification Form to LifeHealth. For additional information contact Nancy Ring at 1-855-762-8978 or 651-638-1000, Monday through Friday, 8:30 AM to 4:30 PM, Central Time or see our website at www.lifehealthmed.com.

    Distribution

    US: Nationwide (AL, AR, CA, CO, FL, IL, IN, IA, KS, KY, MD, MA,MI, MN, MS, MO, NE, NJ, NY,NC, OH, OK, PA, TN, TX, VA) OUS: ALBANIA, BELGIUM, BOLIVIA, CANADA, CHILE, CHINA, DENMARK. DOMINICAN REPUBLIC, ECUADOR, EGYPT, ENGLAND, ESTONIA, PHILIPPINES, FRANCE, GERMANY, GREECE, ICELAND, INDONESIA, IRELAND, ITALY, JAMAICA, JAPAN, MOROCCO, NETHERLANDS, NORWAY, PERU, PORTUGAL, SOUTH AFRICA, SOUTH KOREA, SPAIN, TAIWAN, TUNISIA, TURKEY, UNITED ARAB EMIRATES, VIETNAM.

    Quantity

    1735 boxes of 25. (43375 Cartridges)