PRO-NOX Nitrous Oxide Delivery System (2018-05-09)

Starting date:

May 9, 2018

Posting date:

August 17, 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-67444

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  Reason
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  Affected products

Affected products

PRO-NOX Nitrous Oxide Delivery System

Reason

It was found that a couple of PRO-NOX O2/N2 mixers were reported to have delivered levels of nitrous oxide higher than specifications during routine testing.  No patients were involved.  This recall action taken to perform upgrades to the units in the market.

Affected products