Devices

Device Recall Sarns " TCM II Temperature Control Module

Model / Serial
Catalog Number 4416 and Serial Numbers: 4656, 4657, 4658,4659, 4661, 4662, and 4663.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution including the countries of UAE (United Arab Emirates) HONG KONG and THAILAND. Not distributed in USA
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
Manufacturer
Terumo Cardiovascular Systems Corporation
1 Event
- Recall of Device Recall Sarns " TCM II Temperature Control Module

Manufacturer

Terumo Cardiovascular Systems Corporation

Manufacturer Address
Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
Manufacturer Parent Company (2017)
Terumo Corp.
Source
USFDA

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