Recall Z-1418-2018— Terumo Cardiovascular Systems Corporation

Name: FDA recall Z-1418-2018
Creator: U.S. Food and Drug Administration
Published: 2018-03-16

Class II · Terminated

Class II FDA medical device recall by Terumo Cardiovascular Systems Corporation, initiated 2018-03-16, terminated 2020-06-10. It names one FDA 510(k) clearance: K883603. Product: Sarns TCM II, Catalog Numbers: 4415; 4416;164925; 164930;164935;164940 UDI 00886799000014 The Sarns TCM is indicated for controlling and monitoring patient temperature .. Reason: Update to cooler-heater cleaning instructions..

Recalling firm: Terumo Cardiovascular Systems Corporation
Classification: Class II
Status: Terminated
Initiated: 2018-03-16
Terminated: 2020-06-10
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, Catalog Numbers: 4415; 4416;164925; 164930;164935;164940 UDI 00886799000014 The Sarns TCM is indicated for controlling and monitoring patient temperature .

Reason for recall

Update to cooler-heater cleaning instructions.

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