TherMax Blood Warmer Unit

FDA device recall Z-0247-2020 · posted 2019-10-30 · Terminated

Recall details

Recalling firm

Baxter Healthcare Corporation

Reason for recall

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 taken

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 fca@baxter.com, 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.

Root cause

Device Design

Status

Terminated

Product code

KDI

Quantity affected

504 units total

Distribution

Nationwide distribution to Georgia and Maryland. International distribution to Belgium, Germany, Finland, France, Greece, Italy, Luxemburg, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switze

Date initiated

2019-09-19

Date posted

2019-10-30

Date terminated

2020-12-11

Location

Deerfield, IL

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