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Recall Observatory FDA recall evidence

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

March 16, 2018

Class II

Product summary

Firm
Terumo Cardiovascular Systems Corporation
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

    reason.no_named_rule · v1.0.0

    Update to cooler-heater cleaning instructions.