BEUDAMED
    FDA Recall Terminated

    LifeHealth, IRMA TRUPOINT model 443914, typically used in point-of-care settings. For the in vitro measurement of various critical care analytes in human whole blood. These analytes includes: pO2, pCO2, pH, iCa, Na, K and Cl.

    Recall: Z-1919-2015 · Initiated April 29, 2015

    Recall

    Recall Number
    Z-1919-2015
    Event Number
    71292
    Firm
    LifeHealth, LLC
    FEI Number
    1000115726
    Product Code
    CHL
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 29, 2015
    Posted
    June 27, 2015
    Terminated
    October 20, 2015
    Address
    2656 Patton Rd, Roseville, MN, 55113-1136

    Description

    LifeHealth, IRMA TRUPOINT model 443914, typically used in point-of-care settings. For the in vitro measurement of various critical care analytes in human whole blood. These analytes includes: pO2, pCO2, pH, iCa, Na, K and Cl.

    Reason

    The barometric pressure measurement output of this particular IRMA TRUPoint SN 443914 device will drift over time.

    Action

    Consignees were sent via e-mail a LifeHealth LLC " Urgent" letter dated April, 29th, 2015. The letter described the Purpose of this letter, Reason for the Voluntary Recall, Risk to Health, and Actions to be taken by the Customer. Advised consignees to immediately stop using the recalled product and return it to LifeHealth. Requested consignees to complete and return the Acknowledgement and Receipt Form.

    Distribution

    Worldwide distribution. US in the state of MI; INDONESIA, UNITED ARAB EMIRATES, LITHUANIA, POLAND, and PERU.

    Quantity

    7