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EtCO2 OxyMask, OxyArm - Oxykid and OxyPlus (2017-10-16)
- Starting date:
- October 16, 2017
- Posting date:
- November 10, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-65058
Affected products
A. EtCO2 OxyMask
B. OxyArm- Oxykid
C. OxyArm-OxyPlus
Reason
On October 6, Southmedic received a customer complaint in which the CO2 diffuser of the EtCO2 mask became disconnected from the mask and fell into the patient's mouth. Further inspection of the identified lot number and investigation into root cause identified the potential for loose or missing diffusers in other lots.
Affected products
A. EtCO2 OxyMask
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
OM-2125-14
OM-2125-14SLM
OM-2125-8
Companies
- Manufacturer
-
Southmedic Inc.
50 Alliance Blvd
Barrie
L4M 5K3
CANADA
B. OxyArm- Oxykid
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
OK-2125-8
OK-2125-8SLM
Companies
- Manufacturer
-
Southmedic Inc.
50 Alliance Blvd
Barrie
L4M 5K3
CANADA
C. OxyArm-OxyPlus
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
OP-2125-14
OP-2125-8
OP-2125-8SLM
Companies
- Manufacturer
-
Southmedic Inc.
50 Alliance Blvd
Barrie
L4M 5K3
CANADA