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Recall Observatory FDA recall evidence

Device product

Sarns TCM; The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient The TCM with options will also supply water for cardioplegia, freeze water for an ice supply, monitor temperatures in the patient and extracorporeal circuit, and allow gradient rewarming relative to a venous blood temperature. Product Usage: The Sarns TCM is indicated for controlling and monitoring patient temperature.

Z-2208-2016

June 08, 2016

Class II

Product summary

Firm
Terumo Cardiovascular Systems Corporation
Event
Event 74389
Status
Terminated
Classification
Class II
Quantity
6412 units
Official record key
device-enforcement:Z-2208-2016

Official wording

Reason: Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler devices due to the distributor no longer selling the Interchlor sanitizer (Product Code 205) referenced in its heater-cooler cleaning instructions.

Code information: The Sarns Temperature Control and Monitor unit (TCM), PIN 15747, Catalog Number 15747

Distribution pattern: Domestic: AK, AL, AR, AZ, CA , CO, CT, DC , DE , FL, GA, HI, IA, ID, IL, IN, KS, KY,LA , MA, MD, ME, MI , MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV , NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY Foreign: Argentina, Australia, Belgium,Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, England, Finland, France, Germany Greece, Hong Kong, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Korea, Lebanon, Malaysia Malta, Mexico, Netherlands, New Zealand, Norway, Philippines, Portugal, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates , Uruguay , Venezuela, Vietnam

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler devices due to the distributor no longer selling the Interchlor sanitizer (Product Code 205) referenced in its heater-cooler cleaning instructions.