Z-1418-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 25, 2018
- Initiation Date
- March 16, 2018
- Termination Date
- June 10, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2393- total for all products
Product Description
Sarns TCM II, Catalog Numbers: 4415; 4416;164925; 164930;164935;164940 UDI 00886799000014 The Sarns TCM is indicated for controlling and monitoring patient temperature .
Reason for Recall
Update to cooler-heater cleaning instructions.
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.
Code Information
All Lot Codes