BEUDAMED
    FDA Recall Terminated

    Terumo Capiox NX19 Oxygenator (East Orientation), P/N: CXOT280 Exported only to Japan for inclusion into convenience kits that are sold only within the Japanese market

    Recall: Z-2103-2019 · Initiated June 14, 2019

    Recall

    Recall Number
    Z-2103-2019
    Event Number
    83240
    Firm
    Terumo Cardiovascular Systems Corporation
    FEI Number
    3000204839
    Product Code
    DTZ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 14, 2019
    Terminated
    June 11, 2020
    Address
    125 Blue Ball Rd, Elkton, MD, 21921-5315

    Description

    Terumo Capiox NX19 Oxygenator (East Orientation), P/N: CXOT280 Exported only to Japan for inclusion into convenience kits that are sold only within the Japanese market

    Reason

    Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component

    Action

    Terumo issued Urgent Medical Device Notification letter dated June 13 2019 via FedEx mailing executed on 6/14/2019 advising of the problem, health risk and action to take: Terumo CVS advises users to remove all affected product from inventory and return unused product to Terumo CVS following the instructions provided in this notice. Questions or concerns: Terumo CVS Customer Service: 1.800.521.2818 Monday Friday, 8 a.m. 6 p.m. ET Terumo Recall Fax: 1.410.392.7183 Terumo Recall Email: [email protected]

    Distribution

    MI Foreign: Japan, Belgium

    Quantity

    78 units