Recall Z-1790-2021
Terumo Cardiovascular Systems Corporation · initiated April 16, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
The Sarns Temperature Control and Monitor unit (TCM) 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. The TCM with options will also supply water for cardioplegia, freeze water for an ice supply, monitor temperatures in the patient and extracorporeal circuit, and allow gradient rewarming relative to a venous blood temperature. Device Name / Model Number: TCM II TUV, 115V (P/N 4415), TCM II TUV, 220V (P/N 4416), Catalog Number: 4416, 164940
Codes / lots: All lot numbers distributed from 05/02/1985 thru 06/10/2015
Reason for recall
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.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-1790-2021
- Initiated
- April 16, 2021
- Terminated
- November 29, 2023
- Product code
- DWC – Controller, Temperature, Cardiopulmonary Bypass
- Quantity
- 1176 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, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UNITED ARAB EMIRATES (UAE), Vietnam
- Recalling firm
- Terumo Cardiovascular Systems Corporation, Ann Arbor, MI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1789-2021 Class II | The Terumo HX2 Temperature Management System provides temperature control of two…Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns and… | 04/16/2021Terminated |
| Z-1791-2021 Class II | The Sarns TCM II (system) is a source of temperature-controlled water for blood heat…Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns and… | 04/16/2021Terminated |