Recall Z-0247-2020— Baxter Healthcare Corporation

Name: FDA recall Z-0247-2020
Creator: U.S. Food and Drug Administration
Published: 2019-09-19

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2019-09-19, terminated 2020-12-11. It names one FDA 510(k) clearance: K190910. Product: 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..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Terminated
Initiated: 2019-09-19
Terminated: 2020-12-11
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K190910 — PrisMax System Version 2Baxter Healthcare Corp·cleared 2019-07-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

TherMax Blood Warmer Unit

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.