Health product recall

Equinox Relieve and Equinox Relieve II Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System (2018-05-07)

Starting date:
May 7, 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-66884

Affected products

  1. Equinox Relieve Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System
  2. Equinox Relieve II Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System

Reason

The manufacturer was made aware that two pro-nox (private labelled from equinox relieve) O2/N2O mixers were reported to have delivered levels of nitrous oxide higher than specifications during routine testing.  There was no patient involvement in either case.

Affected products

A. Equinox Relieve Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System

Lot or serial number

CMI-1026-2012
EQ1004-12
EQ1005-2012
EQ1479-16 to EQ1495-16

Model or catalog number

01EQ1000

Companies
Manufacturer
O-Two Medical Technologies Inc.
45A Armthorpe Road
Brampton
L6T 5M4
Ontario
CANADA

B. Equinox Relieve II Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System

Lot or serial number

EQF1046--16 to EQF1045-16
EQF1051-2017 to EQF1052-2017

Model or catalog number

01EQ1000F

Companies
Manufacturer
O-Two Medical Technologies Inc.
45A Armthorpe Road
Brampton
L6T 5M4
Ontario
CANADA