Sarns TCM II Cooling and Heating Systems (2018-04-06)
- Starting date:
- April 6, 2018
- Posting date:
- May 25, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-66876
Affected products
Sarns TCM II Cooling and Heating Systems
Reason
As part of on-going discussions with the U.S. Food And Drug Administration (FDA) regarding cooler-heater cleaning guide adequacy, Terumo Cardiovascular Systems (CVS) has updated its cooler-heater instructions for use (cleaning guides). Terumo CVS is issuing updates to its cleaning guides for specific products in order to provide customers with the most up-to-date information possible and to reduce the potential risk of Non-Tuberculous Mycobacteria (NTM) infections associated with heater-cooler devices.
Affected products
Sarns TCM II Cooling and Heating Systems
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
4415
Companies
- Manufacturer
-
Terumo Cardiovascular Systems Corp.
6200 Jackson Road
Ann Arbor
48103
Michigan
UNITED STATES