Terumo Cardiovascular Systems Corporation: Medical Device Recall in 2013 - (Recall #: Z-1569-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: May 30, 2013

Date Posted: July 3, 2013

Recall Number: Z-1569-2013

Event ID: 64530

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.

Status: Terminated

Product Quantity: 7 units

Code Information:

Catalog Number 4416 and Serial Numbers: 4656, 4657, 4658,4659, 4661, 4662, and 4663.

Distribution Pattern:

Worldwide Distribution including the countries of UAE (United Arab Emirates) HONG KONG and THAILAND. Not distributed in USA

Voluntary or Mandated:

Voluntary: Firm initiated