BEUDAMED
    FDA Recall Terminated

    CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters Model: CL10021021

    Recall: Z-1716-2015 · Initiated April 27, 2015

    Recall

    Recall Number
    Z-1716-2015
    Event Number
    71093
    Firm
    Fresenius Medical Care Holdings, Inc.
    FEI Number
    3001451489
    Product Code
    KOC
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    April 27, 2015
    Posted
    June 5, 2015
    Terminated
    February 18, 2021
    Address
    920 Winter St, Waltham, MA, 02451-1521

    Description

    CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters Model: CL10021021

    Reason

    Blood chamber connection leaks during the use of the CRIT-LINE Blood Chamber

    Action

    Fresenius LLC North America notified accounts by letter sent certified mail on May 22, 2015, expanding the recall to All lots. Previously recall letters were on April 30, 2015, 2nd notice on May 14, 2015. Users are requested to examine inventory, discontinue use and return product. Contact FMCRTG, LLC Customer Service Team 1-800-323-5188 for instructions. A reply form is included as part of the customer communication with instructions to fill out and return via fax or scanned/emailed copy. Confirmation of delivery will be obtained through the use of registered mail.

    Distribution

    Worldwide Distribution - Nationwide Distribution including Puerto Rico., and the countries of : Ireland, Spain, Slovenia, Great Britain, Netherlands, Norway, Mexico, Egypt, Czech Republic and Spain.

    Quantity

    22,640,288