Plasma Sterilizers - HMTS (2017-04-30)

Starting date:

April 30, 2017

Posting date:

June 1, 2017

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Hospitals, Healthcare Professionals

Identification number:

RA-63412

• Reason
• Affected products

Affected Products

1. Plasma Sterilizer - Hmts-80
2. Plasma Sterilizer - Hmts-80a
3. Plasma Sterilizer - Hmts-Ses
4. Plasma Sterilizer - Hmts-142
5. Plasma Sterilizer Hmts-40e
6. Plasma Sterilizer Hmts-80e
7. Plasma Sterilizer Hmts-30e

Reason

Results of further testing performed on the HMTS Sterilant Agent used in these sterilizers demonstrate that the expiry date of the Sterilant can be extended from 1 year to 2 years. As a result, the software in the HMTS plasma sterilizers must be updated in order to recognize this extended time of expiry. This recall is being initiated in order for SciCan technicians to perform this software update. There is no safety issue related to this recall and the units can continue to be used.

Affected products