BEUDAMED
    FDA Recall Terminated

    Crit Line in a Clip (CLiC). CliC P/N: CL 10041001 CLiC is a continuous real-time monitor for non-invasive hematocrit oxygen saturation and percent change in blood volume measurement during hemodialysis treatment. Used in conjunction with the Fresenius 2008T Hemodialysis Machines as follows: Model: 190895 2008T GEN 2 BIBAG w/o CDX 190713 2008T Hemodialysis SYS with CDX 190858 2008T Hemodialysis System w/o CDX 190766 2008T Hemodialysis System w/o CDX

    Recall: Z-2044-2016 · Initiated May 24, 2016

    Recall

    Recall Number
    Z-2044-2016
    Event Number
    74241
    Firm
    Fresenius Medical Care Renal Therapies Group, LLC
    FEI Number
    3001451489
    Product Code
    KOC
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 24, 2016
    Terminated
    April 30, 2021
    Address
    920 Winter St, Waltham, MA, 02451-1521

    Description

    Crit Line in a Clip (CLiC). CliC P/N: CL 10041001 CLiC is a continuous real-time monitor for non-invasive hematocrit oxygen saturation and percent change in blood volume measurement during hemodialysis treatment. Used in conjunction with the Fresenius 2008T Hemodialysis Machines as follows: Model: 190895 2008T GEN 2 BIBAG w/o CDX 190713 2008T Hemodialysis SYS with CDX 190858 2008T Hemodialysis System w/o CDX 190766 2008T Hemodialysis System w/o CDX

    Reason

    Use of the Blood Pressure Graph located on the Crit-Line screen of the 2008T Hemodialysis Machine may result in a frozen screen, possibly causing the blood pump to stop.

    Action

    Fresenius Medical Care Renal Therapies Group, LLC issued Recall Letter issued 5/24/16 via certified mail. Clinics actively using the CLiC option have been verbally communicated to stop using the CLiC option at . The other clinics that did not activate the CLiC option have been verbally communicated to not activate the CLiC option at this time. A Software update to all 2008T Hemodialysis machines will be required. A reply form is included as part of the customer communication with instructions to fill out and return via fax or scanned/emailed copy. For technical Inquiries, please contact Technical Services at 1-800-227-2572. Additional medical concerns or questions, please contact the Medical Information and Communication line at 855-616-2309 or website www.fresenius-medinfo.com.

    Distribution

    Distributed US (nationwide)

    Quantity

    875 units