BEUDAMED
    FDA Recall Terminated

    ThermaSure(TM), a CENORIN(TM) product, SERIES 1000 MEDICAL DEVICE DRYER: (a) Model 1009; (b) Model 1010 Forced air dryer for medical devices

    Recall: Z-3034-2017 · Initiated June 7, 2017

    Recall

    Recall Number
    Z-3034-2017
    Event Number
    77637
    Firm
    Cenorin, LLC
    FEI Number
    3004153171
    Product Code
    JRJ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 7, 2017
    Terminated
    May 2, 2018
    Address
    6324 S 199th Pl, Suite 107, Kent, WA, 98032

    Description

    ThermaSure(TM), a CENORIN(TM) product, SERIES 1000 MEDICAL DEVICE DRYER: (a) Model 1009; (b) Model 1010 Forced air dryer for medical devices

    Reason

    Dryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or burn.

    Action

    Cenorin initially contacted all domestic customers at the facility and distributor level via phone on June 7, 2017, which was followed by an Urgent Medical Device Recall letter dated July 20, 2017, to all affected customers. Cenorin sent initial notification to international distributors via email. Customers were asked to immediately examine their inventory for the affected product. If the product exhibits any symptoms of failure, immediately cease using it and contact Cenorin immediately at [email protected] or call Technical Support at 800-426-1042, ext 224.

    Distribution

    Worldwide Distribution - US (Nationwide) Internationally to Japan, Hong Kong, Brunei, and Israel

    Quantity

    18 units