BIOCAL 370 Temperature Controller (2018-02-08)

Starting date:

February 8, 2018

Posting date:

March 2, 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-66074

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  Reason
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  Affected products

Affected products

BIOCAL 370 Temperature Controller

Reason

Safety issues were raised by regulators regarding water systems quality of temperature controllers, regardless of manufacturer. Medtronic specifically assessed the associated risk with the use of the Medtronic BIOCAL heater/cooler model 370. The potential hazard associated was identified as the presence of mycobacterium in the operating room due to the BIOCAL device not cleaned /disinfected on a regular basis, or the use of non- deionized water.

Affected products