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Health product recall

Sarns Temperature Control Module (TCM II) (2016-07-06)

Starting date:
July 6, 2016
Posting date:
July 22, 2016
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-59506

Affected products

A. Sarns Temperature Control Module (TCM II)

Reason

Terumo Cardiovascular Systems (Terumo CVS) and Ryan Medical Distributors Inc is notifying its users of its heater-cooler devices that the distributor, Intercon Chemical Company, no longer sells the Interchlor Sanitizer (product code 205) referenced in its heater-cooler cleaning instructions. However, the identical sanitizer is available from other sources.

Affected products

A. Sarns Temperature Control Module (TCM II)

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
Michigan
UNITED STATES