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