Terumo Cardiovascular Systems Corporation: 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 determined that the best course of action is for users to discontinue use of and dispose of HX2, TCM I and TCM II devices.

Agency Publication Date: June 4, 2021

Affected Products

Product: The Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery. The system consists of a water tank, circulating pumps, heater manifolds, mercury free temperature sensors, water detectors, mixing valves and a tank divider which is provided to partition the tank into two separate channels (Left and Right). The system has the capacity to

All lot numbers distributed from 05/02/1985 thru 06/10/2015

Lot Numbers:

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Product: 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. Device Name / Model Number: TCM II TUV, 115V (P/N 4415

All lot numbers distributed from 05/02/1985 thru 06/10/2015

Lot Numbers:

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Product: 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:

All lot numbers distributed from 05/02/1985 thru 06/10/2015

Lot Numbers:

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Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87834

Status: Resolved

Manufacturer: Terumo Cardiovascular Systems Corporation

Manufactured In: United States

Units Affected: 3 products (75 devices; 1176 devices; 995 devices)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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Affected Products

All lot numbers distributed from 05/02/1985 thru 06/10/2015

Lot Numbers:

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All lot numbers distributed from 05/02/1985 thru 06/10/2015

Lot Numbers:

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All lot numbers distributed from 05/02/1985 thru 06/10/2015

Lot Numbers:

numbers