The Sarns TCM II (system) 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. It also freezes water for an ice supply, monitors temperatures in the patient and extracorporeal circuit, and allows gradient rewarming relative to a venous blood temperature. The Sarns" TCM II also features a Cardioplegia System which will supply cooling water for cardioplegia. Device Name / Model Number:

Recall Insight

This FDA Devices action (record #Z-1791-2021) was formally reported on June 9, 2021, with the manufacturer initiating the action on April 16, 2021. It is classified under Moderate severity (Class II), with a current status of Terminated. Terumo Cardiovascular Systems Corporation is listed as the recalling firm, operating out of Ann Arbor, MI. Federal records list the affected scope as 995 devices.

The documented reason for this recall is: Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns and expectations. As a result, an updated cleaning protocol will not be developed by Terumo CVS and it has been determine… Distribution data in the federal record shows the product reached: Domestic: Foreign: Australia, Belgium, Canada, Chile, China, Colombia, Dominican Republic, England, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Israel, Italy, Japan, Korea, Malaysia, Mexico, Netherlands,…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.