BEUDAMED
    FDA Recall Terminated

    TherMax Blood Warmer Unit

    Recall: Z-0247-2020 · Initiated September 19, 2019

    Recall

    Recall Number
    Z-0247-2020
    Event Number
    83816
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    KDI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 19, 2019
    Posted
    October 30, 2019
    Terminated
    December 11, 2020
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    TherMax Blood Warmer Unit

    Reason

    TherMax Blood Warmers may not be in compliance with an electrical safety standard, which requires a protective earth connection that can sustain a current of 25 amps for 10 seconds.

    Action

    Baxter Healthcare notified customers on about 09/19/2019, via "URGENT MEDICAL DEVICE CORRECTION" letter. Customers were informed that specific TherMax Blood Warmers listed below may not be in compliance with an electrical safety standard, which requires a protective earth connection that can sustain a current of 25 amps for 10 seconds. The affected units may not have an adequate ground path, which could cause the units to become damaged if used with improperly grounded outlets. The damage could cause the TherMax Blood Warmer units to be nonfunctional during clinical use. Instructions included that customers could continue to safely use affected devices with a properly grounded outlet, that a local Baxter representative will contact each facility to arrange for the correction of affected devices, to complete and return the Baxter Customer Reply Form via fax to 224-270-5457 or scanning and e-mailing it to [email protected], and to notify customers if the product was further distributed. For general questions regarding this communication, contact Baxter Corporate Product Surveillance at 800-437-5176, between the hours of 8:00 am and 5:00 pm Central Time, Monday through Friday.

    Distribution

    Nationwide distribution to Georgia and Maryland. International distribution to Belgium, Germany, Finland, France, Greece, Italy, Luxemburg, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, United Kingdom, Australia, and New Zealand

    Quantity

    504 units total