Sarns TCM II, Catalog Numbers: 4415; 4416;164925; 164930;164935;164940 UDI 00886799000014 The Sarns TCM is indicated for controlling and monitoring patient temperature .
Reported: April 25, 2018 Initiated: March 16, 2018 #Z-1418-2018
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.
Details
- Recalling Firm
- Terumo Cardiovascular Systems Corporation
- Units Affected
- 2393- total for all products
- 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.
- Location
- Ann Arbor, MI
Frequently Asked Questions
What product was recalled? ▼
Sarns TCM II, Catalog Numbers: 4415; 4416;164925; 164930;164935;164940 UDI 00886799000014 The Sarns TCM is indicated for controlling and monitoring patient temperature .. Recalled by Terumo Cardiovascular Systems Corporation. Units affected: 2393- total for all products.
Why was this product recalled? ▼
Update to cooler-heater cleaning instructions.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 25, 2018. Severity: Moderate. Recall number: Z-1418-2018.
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