BEUDAMED
    FDA Enforcement Class II 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 · Reported July 8, 2015

    Enforcement

    Recall Number
    Z-1919-2015
    Event ID
    71292
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    LifeHealth, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 8, 2015
    Initiation Date
    April 29, 2015
    Classification Date
    June 26, 2015
    Termination Date
    October 20, 2015
    Address
    2656 Patton Rd, Roseville, MN, 55113-1136, United States

    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.

    Code Info

    44803, 44805, 44807, 44808, 44818, 44830, 44837

    Distribution

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

    Quantity

    7