Recall Z-1569-2013— Terumo Cardiovascular Systems Corporation

Name: FDA recall Z-1569-2013
Creator: U.S. Food and Drug Administration
Published: 2013-05-30

Class II · Terminated

Class II FDA medical device recall by Terumo Cardiovascular Systems Corporation, initiated 2013-05-30, terminated 2013-09-17. It names one FDA 510(k) clearance: K883603. 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. Reason: Internal testing found certain Sarns" TCM II systems were released with incorrectly assembled heatsink assemblies which could cause the units to fail..

Recalling firm: Terumo Cardiovascular Systems Corporation
Classification: Class II
Status: Terminated
Initiated: 2013-05-30
Terminated: 2013-09-17
Firm location: Ann Arbor, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K883603 — SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II)3M Health Care, Sarns·cleared 1988-11-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.