Recall Z-0417-2020— Cincinnati Sub-Zero Products LLC, a Gentherm Company

Name: FDA recall Z-0417-2020
Creator: U.S. Food and Drug Administration
Published: 2019-07-02

Class II · Terminated

Class II FDA medical device recall by Cincinnati Sub-Zero Products LLC, a Gentherm Company, initiated 2019-07-02, terminated 2020-06-22. It names one FDA 510(k) clearance: K101589. Product: Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature management Model 233 - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.. Reason: Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Additionally, a caution was added and clarifications were made regarding the use of the Automatic modes.

Recalling firm: Cincinnati Sub-Zero Products LLC, a Gentherm Company
Classification: Class II
Status: Terminated
Initiated: 2019-07-02
Terminated: 2020-06-22
Firm location: Cincinnati, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K101589 — BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMSCincinnati Sub-Zero Products, Inc.·cleared 2010-09-20

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

Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature management Model 233 - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.

Reason for recall

Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Additionally, a caution was added and clarifications were made regarding the use of the Automatic modes

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