Recall Z-0825-2019 ยท DWC Controller, Temperature, Cardiopulmonary Bypass
Cincinnati Sub-Zero Products LLC, a Gentherm Company
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 al
| Date | Dec 19, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | 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. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122813 | HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM Cincinnati Sub-Zero Products, Inc., Dec 18, 2012 |