Device product
Sarns TCM II, Catalog Numbers: 4415; 4416;164925; 164930;164935;164940 UDI 00886799000014 The Sarns TCM is indicated for controlling and monitoring patient temperature .
Z-1418-2018
Product summary
- Event
- Event 79652
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2393- total for all products
- Official record key
device-enforcement:Z-1418-2018
Official wording
Reason: Update to cooler-heater cleaning instructions.
Code information: All Lot Codes
Distribution pattern: Worldwide Distribution: US (Nationwide), Australia, Belgium, Canada, Chile, China. Colombia, Dominican Republic, England, Finland, France, Germany, Greece, HK, India, Indonesia, Iran. Israel, Italy, Japan, Korea, Mexico, Netherlands, New Zealand, Norway, Philippines, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates,and Vietnam.
Derived failure modes
-
Unknown
Update to cooler-heater cleaning instructions.