OxyArm - OxyMask model-RTM and OxyArm - OxyPlus (2019-06-04)
- Starting date:
- June 4, 2019
- Posting date:
- June 21, 2019
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-70253
Last updated: 2019-06-21
Affected Products
A. OxyArm - OxyMask model -RTM
B. OxyArm - OxyPlus
Reason
Southmedic is conducting a voluntary recall due to possible occlusion of the CO2 sampling line. When connected to an EtCO2 monitor, line occlusion may lead to an "occlusion"-type error on the monitor. This does not affect the masks' ability to provide oxygen delivery.
Affected products
A. OxyArm - OxyMask model -RTM
Lot or serial number
W52086
W52497
W53877
Model or catalog number
OM-2125-8
Companies
- Manufacturer
-
Southmedic Inc.
50 Alliance Blvd
Barrie
L4M 5K3
Ontario
CANADA
B. OxyArm - OxyPlus
Lot or serial number
W53523
Model or catalog number
OP-2125-8
Companies
- Manufacturer
-
Southmedic Inc.
50 Alliance Blvd
Barrie
L4M 5K3
Ontario
CANADA