Z-1569-2013Class II

Sarns " TCM II Temperature Control Module The Sarns" TCM II Temperature Control Module is a source of...

Name: Z-1569-2013 Sarns " TCM II Temperature Control Module The Sarns" TCM II Temperature Control Module is a source of...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2013-05-30
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2013-05-30 / Terminated / root cause: manufacturing process

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Sarns " TCM II Temperature Control Module The Sarns" TCM II Temperature Control Module is a source of temperature-controlled water for blood heat exchangers... on 2013-05-30. FDA classified it as Class II and gives the reason as "Internal testing found certain Sarns" TCM II systems were released with incorrectly assembled heatsink assemblies which could cause the units to fail". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1569-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-30
Posted: 2013-06-21
Terminated: 2013-09-17
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Sarns " TCM II Temperature Control Module The Sarns" TCM II Temperature Control Module is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and is indicated for controlling and monitoring patient temperature
Product code: DWC Controller, Temperature, Cardiopulmonary Bypass
Reason for recall: Internal testing found certain Sarns" TCM II systems were released with incorrectly assembled heatsink assemblies which could cause the units to fail.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Terumo sent beginning May 30, 2013, an URGENT MEDICAL DEVICE RECALL NOTIFICATION were sent to all customers with instructions to notify all customers of the recall requesting all affected units to be quarantined until the heatsink units are replaced Confirm receipt by filling out the response form containing communication by faxing or emailing the attached Affiliate Response Form to the fax number or email address indicated on the form. Questions should be directed to Terumo CVS customer service in the U.S.: Telephone: +1-734-663-4145; Fax: +1-734-741-6149
Quantity in commerce: 7 units
Distribution: Worldwide Distribution including the countries of UAE (United Arab Emirates) HONG KONG and THAILAND. Not distributed in USA
Product codes and lots: Catalog Number 4416 and Serial Numbers: 4656, 4657, 4658,4659, 4661, 4662, and 4663.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1569-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1569-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-21

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)