FDA Enforcement
Class II
Terminated
Sarns TCM II, Catalog Numbers: 4415; 4416;164925; 164930;164935;164940 UDI 00886799000014 The Sarns TCM is indicated for controlling and monitoring patient temperature .
Recall: Z-1418-2018
·
Reported April 25, 2018
Enforcement
- Recall Number
- Z-1418-2018
- Event ID
- 79652
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Terumo Cardiovascular Systems Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 25, 2018
- Initiation Date
- March 16, 2018
- Classification Date
- April 17, 2018
- Termination Date
- June 10, 2020
- Address
- 6200 Jackson Rd, Ann Arbor, MI, 48103-9586, United States
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
Update to cooler-heater cleaning instructions.
Code Info
All Lot Codes
Distribution
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.
Quantity
2393- total for all products