Home / Recalls / Cincinnati Sub-Zero Products LLC, a Gentherm Company / Z-0063-2019

Z-0063-2019 Class II Terminated

Recalled by Cincinnati Sub-Zero Products LLC, a Gentherm Company — Cincinnati, OH

Recall Details

Product Type
Devices
Report Date
October 10, 2018
Initiation Date
September 4, 2018
Termination Date
May 23, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
270 units

Product Description

Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm¿ 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

Potential for membrane (control panel) switch errors leading to an inability of the device to change control settings or an unintended change to control settings.

Distribution Pattern

US Nationwide Distribution

Code Information

UDI 10613031860221

Other recalls by Cincinnati Sub-Zero Products LLC, a Gentherm Company

  • Z-2291-2019 Class III — MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to wa (July 19, 2019)
  • Z-0419-2020 Class II — CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool - P (July 2, 2019)
  • Z-0417-2020 Class II — Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature man (July 2, 2019)
  • Z-0418-2020 Class II — Blanketrol II Hyper-Hypothermia System, Models 222R and 222S - Product Usage: T (July 2, 2019)
  • Z-2355-2019 Class II — Norm-O-Temp model 111Z (June 20, 2019)
  • Z-2356-2019 Class II — Norm-O-Temp model 111W (June 20, 2019)
  • Z-0825-2019 Class II — Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE Product Usage: Th (December 19, 2018)