Recall Z-1417-2018— Terumo Cardiovascular Systems Corporation

Name: FDA recall Z-1417-2018
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: K841402. Product: Sarns TCM, Catalog No. 15747 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

K841402 — TEMPERATURE CONTROL & MONITORSams, Inc.·cleared 1984-06-11

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, Catalog No. 15747 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.