Z-1791-2021Class II

The Sarns TCM II (system) is a source of temperature-controlled water for blood heat exchangers used in an...

Name: Z-1791-2021 The Sarns TCM II (system) is a source of temperature-controlled water for blood heat exchangers used in an...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2021-04-16
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2021-04-16 / Terminated / root cause: design

FDA source

Terumo Cardiovascular Systems Corporation began a recall of 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... on 2021-04-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1791-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-16
Posted: 2021-06-04
Terminated: 2023-11-29
Recalling firm: Terumo Cardiovascular Systems Corporation
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: TCM II, with Cardioplegia, 110V/60Hz (P/N 164925) TCM II, without Cardioplegia, 110V/60Hz (P/N 164930) TCM II, with Cardioplegia, 220V/50Hz (P/N 164935) TCM II, without Cardioplegia, 220V/50Hz (P/N 164940) TCM (P/N 15747) Catalog Number: 4415, 164925, 164930, 164935, 15747
Product code: DWC Controller, Temperature, Cardiopulmonary Bypass
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.
Root cause tag: design
FDA root cause: Device Design
Action: On 04/30/2021, Terumo issued an Urgent Medical Device Removal notice to customer via letter notifying users to discontinue the use of and dispose of HX2, TCM I and TCM II devices. Customers were instructed to confirm receipt of this communication by completing and returning the attached Customer Response Form as indicated on the form. For questions contact Terumo CVS Customer Service: 1-800-521-2818.
Quantity in commerce: 995 devices
Distribution: 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
Product codes and lots: All lot numbers distributed from 05/02/1985 thru 06/10/2015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1791-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1789-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-04
Z-1790-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-04
Z-1791-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-04

Product code DWC

K883603Class IISarns Temp. Control and Monitor System (Tcm II)3M Health Care, Sarns / cleared 1988-11-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)