CLASS II Device recall · Reported 9 Jun 2021 · FDA Enforcement Report

The Sarns Temperature Control and Monitor unit (TCM) is a source recalled

Terumo Cardiovascular Systems is recalling The Sarns Temperature Control and Monitor unit (TCM) is a source of. The recall was initiated on 16 Apr 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lot numbers distributed from 05/02/1985 thru 06/10/2015

Quantity recalled1176 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1790-2021
FDA event ID: 87834
Recalling firm: Terumo Cardiovascular Systems, Ann Arbor, MI
Classification: Class II
Status: Terminated
Recall initiated: 16 Apr 2021
FDA classified: 4 Jun 2021
Reported: 9 Jun 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Temperature Abuse
Device type: Patient Monitors

Timeline

16 Apr 2021	Recall initiated by company
4 Jun 2021	Classified by FDA	+49 days
9 Jun 2021	Published in enforcement report	+5 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.

Product as listed by the FDA

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), TCM II TUV, 220V (P/N 4416), Catalog Number: 4416, 164940

Where it was distributed

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, New Zealand, Norway, Philippines, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UNITED ARAB EMIRATES (UAE), Vietnam

Stores named: CVS

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 87834

This product is part of a recall event; the main page for the event is The Sarns TCM II (system) is a source recalled.

Reported	Class	Recall	Company	Reason	Where
9 Jun 2021	CLASS II	The Sarns TCM II (system) is a source recalled	Terumo Cardiovascular Systems	Temperature Abuse	MI
9 Jun 2021	CLASS II	The Terumo HX2 Temperature Management System provides recalled	Terumo Cardiovascular Systems	Temperature Abuse	MI

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