Recall Z-0825-2019
Cincinnati Sub-Zero Products LLC, a Gentherm Company · initiated December 19, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Serial numbers 151-10283CE through 171-10721CE
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.
FDA-determined cause: Device Design
Action taken
Initial notification letters were sent to customers on 12/19/18 to inform them of the upcoming field action. An additional letter sent to customers on 1/18/19 providing instructions on the correction. The letter identified the affected product, problem and actions to be taken.
Details
- Recall number
- Z-0825-2019
- Initiated
- December 19, 2018
- Terminated
- April 24, 2020
- Product code
- DWC – Controller, Temperature, Cardiopulmonary Bypass
- Quantity
- 396
- Distribution
- Worldwide Distribution - US Nationwide in the states of: AL, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, VA, and WI. The products were distributed to the following foreign countries: Columbia and Taiwan.
- Recalling firm
- Cincinnati Sub-Zero Products LLC, a Gentherm Company, Cincinnati, OH