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

• Reason
• Affected products

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