This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
Southmedic Oxygen Masks (2017-02-15)
- Starting date:
- February 15, 2017
- Posting date:
- March 24, 2017
- 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-62776
Affected Products
A. Ophthalmic Capnoxygen Mask
B. OxyArm-OxyMask Model - RTM
C. OxyArm-OxyPlus
Reason
On February 14, Southmedic received a customer complaint indicating a potential occlusion of the CO2 sampling line on a Southmedic Capnography Mask. Inspection of current stock of the lot number in question did not identify any issues however investigation into additional lots manufactured with the same subassembly resulted in identification of occluded CO2 sampling lines. Subsequently all stock of various product stock keeping units (SKUs) manufactured with a CO2 sampling line were placed on hold for further inspection.
Affected products
A. Ophthalmic Capnoxygen Mask
Lot or serial number
W35906
W35983
Model or catalog number
CO2-01-SLM
CO2-03-SLM
Companies
- Manufacturer
-
Southmedic Inc.
50 Alliance Blvd
Barrie
L4M 5K3
Ontario
CANADA
B. OxyArm-OxyMask Model - RTM
Lot or serial number
W35266
Model or catalog number
OM-2125-8
Companies
- Manufacturer
-
Southmedic Inc.
50 Alliance Blvd
Barrie
L4M 5K3
Ontario
CANADA
C. OxyArm-OxyPlus
Lot or serial number
W35909
Model or catalog number
OP-2125-8
Companies
- Manufacturer
-
Southmedic Inc.
50 Alliance Blvd
Barrie
L4M 5K3
Ontario
CANADA