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
- Recall Initiated
- April 16, 2021
- Terminated
- November 29, 2023
- Recall Number
- Z-1790-2021
- Quantity
- 1176 devices
- Firm Location
- Ann Arbor, MI
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.
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
Lot / Code Info
All lot numbers distributed from 05/02/1985 thru 06/10/2015
Root 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.