Recall Z-1791-2021 ยท DWC Controller, Temperature, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
The Sarns TCM II (system) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient. It also freezes water for an ice supply, monitors temperatures in the patient and extracorporeal circuit, and allows gradient rewarming relative to a venous blood temperature. The Sarns" TCM II also features a Ca
| Date | Apr 16, 2021 |
| Status | Terminated |
| Reason | Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns and expectations. As a result, an updated cleaning protocol will not be developed by Terumo CVS and it has been determined that the best course of action is for users to discontinue use of and dispose of HX2, TCM I and TCM II devices. |
| Root cause | Device Design |
| Action | On 04/30/2021, Terumo issued an Urgent Medical Device Removal notice to customer via letter notifying users to discontinue the use of and dispose of HX2, TCM I and TCM II devices. Customers were instructed to confirm receipt of this communication by completing and returning the attached Customer Response Form as indicated on the form. For questions contact Terumo CVS Customer Service: 1-800-521-2818. |
| Quantity | 995 devices |
| Distribution | Domestic: Foreign: Australia, Belgium, Canada, Chile, China, Colombia, Dominican Republic, England, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Israel, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, New Zealand, Norway, Philippines, Russia, Saudi Arabia, Singapore, South Korea, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K883603 | SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II) 3M Health Care, Sarns, Nov 3, 1988 |