BEUDAMED
    FDA Recall Terminated

    Vacuum Unit for CATSmart Vacuum Pump. Fresenius CATSmart (Continuous Autotransfusion System) is indicated for the processing of blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion.

    Recall: Z-1059-2019 · Initiated February 11, 2019

    Recall

    Recall Number
    Z-1059-2019
    Event Number
    82194
    Firm
    Fenwal Inc
    FEI Number
    3004548776
    Product Code
    CAC
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 11, 2019
    Terminated
    June 23, 2020
    Address
    3 Corporate Dr, Ste 300, Lake Zurich, IL, 60047-8930

    Description

    Vacuum Unit for CATSmart Vacuum Pump. Fresenius CATSmart (Continuous Autotransfusion System) is indicated for the processing of blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion.

    Reason

    The optional Vacuum Unit may stop working and display the failure message "Failure vacuum unit" during use.

    Action

    The firm, Fresenius Kabi, sent the initial distributor a notification on about 02/11/2019 via email. Consignees were notified on about 02/18/2019 via "IMPORTANT - VACUUM UNIT for CATSmart ISSUE" letter dated 2/7/2019. Instructions inducted that the device can still be used and there are not restrictions on the washing process. If an incident is experienced, customers are directed to contact Technical Service at 1-800-937-5060 and to provide the serial number of the device. Fresenius Kabi will be modifying the vacuum pump with a new cable mechanism to provide a secure long-term connection and updated firmware allowing for a consistent signal to the CATSmart device. The modifications will be implemented at customer locations and completed by September 1, 2019. Customers were also instructed to complete and return the Customer Reply form via fax to:1-847-550-0032. If you have any questions, please contact the Fresenius Kabi Technical Service at 800- 937-5060. prompt 2.

    Distribution

    US Nationwide Distribution to states of: AZ, CA, FL, HI, ID, IL, IN, MD, MI, MN, MO, NC, ND, NE, NJ, NV, NY, OK, OR, PA, TN, TX, VA and PR; and Internationally to Canada.

    Quantity

    198 devices