Terumo Cardiovascular Systems Corporation recalls Sarns TCM II, Catalog Numbers: 4415; 4416;164925; 164930;164935;164940 UDI 00886799000014 The Sarns TCM is indicated fo…
- Recall date
- March 16, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1418-2018
- FDA classification
- Class II
- Brand / firm
- Terumo Cardiovascular Systems Corporation
- Sold / distributed
- 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…
Why it was recalled
Update to cooler-heater cleaning instructions.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What 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 .
Get recall alerts
Free email alert whenever Terumo Cardiovascular Systems Corporation has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Terumo Cardiovascular Systems Corporation