Recall Z-0825-2019— Cincinnati Sub-Zero Products LLC, a Gentherm Company

Name: FDA recall Z-0825-2019
Creator: U.S. Food and Drug Administration
Published: 2018-12-19

Class II · Terminated

Class II FDA medical device recall by Cincinnati Sub-Zero Products LLC, a Gentherm Company, initiated 2018-12-19, terminated 2020-04-24. It names one FDA 510(k) clearance: K122813. Product: Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE Product Usage: The HEMOTHERM¿ Model 400CE Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator / Heat Exchanger that is used to cool or warm blood during cardiopulmonary bypass procedures lasting six hours or less. The Hemotherm Dual Reservoir Cooler/Heater may also be used with a hyper / hypothermia blanket under the patient to provide warming through conductive heat transfer.. Reason: Evidence supports that when customers performed a fuse replacement as part of a March 2017 field action, the fuse clips became stretched and were no longer mechanically tight with the fuse, creating a host spot that led to discoloration on the board due to overheating and shut down of the device..

Recalling firm: Cincinnati Sub-Zero Products LLC, a Gentherm Company
Classification: Class II
Status: Terminated
Initiated: 2018-12-19
Terminated: 2020-04-24
Firm location: Cincinnati, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K122813 — HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEMCincinnati Sub-Zero Products, Inc.·cleared 2012-12-18

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

Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE Product Usage: The HEMOTHERM¿ Model 400CE Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator / Heat Exchanger that is used to cool or warm blood during cardiopulmonary bypass procedures lasting six hours or less. The Hemotherm Dual Reservoir Cooler/Heater may also be used with a hyper / hypothermia blanket under the patient to provide warming through conductive heat transfer.

Reason for recall

Evidence supports that when customers performed a fuse replacement as part of a March 2017 field action, the fuse clips became stretched and were no longer mechanically tight with the fuse, creating a host spot that led to discoloration on the board due to overheating and shut down of the device.

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