BEUDAMED
    FDA Recall Terminated

    Fresenius Crit Line in a Clip (CLiC) with SW version 2.51 Model Number: CL10041001. A continuous real-time monitor for non-invasive hematocrit, oxygen saturation and percent change in blood volume calculation during hemodialysis treatment.

    Recall: Z-1047-2015 · Initiated December 19, 2014

    Recall

    Recall Number
    Z-1047-2015
    Event Number
    70288
    Firm
    Fresenius Medical Care Holdings, Inc.
    FEI Number
    3001451489
    Product Code
    KOC
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 19, 2014
    Posted
    February 3, 2015
    Terminated
    February 18, 2021
    Address
    920 Winter St, Waltham, MA, 02451-1521

    Description

    Fresenius Crit Line in a Clip (CLiC) with SW version 2.51 Model Number: CL10041001. A continuous real-time monitor for non-invasive hematocrit, oxygen saturation and percent change in blood volume calculation during hemodialysis treatment.

    Reason

    Potential for misinterpretation of the graphic display of the Blood Volume ( BV) slope

    Action

    FMCRTG, LLC representatives contacted Clinics on 12/19/14 by visit/telephone phone) and removed all CLiC units.

    Distribution

    CT, NY

    Quantity

    35 units