Public recall detail

Oxy2Mask

2024-01-19

medium
Recall Safety notice
Quick summary

Quick summary: Oxy2Mask. Date: 2024-01-19.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Oxy2Mask. Date: 2024-01-19.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandSouthmedic Inc.
ProductOxy2Mask
IssueMedical devices - Device compatibility
Recall classType II
IdentificationRA-74934

Affected products

ProductAffected products
LotLot or serial number
ModelModel or catalog number/
Serial numberLot or serial number
DescriptionAffected products
ProductOxy2Mask O2/ETCO2
LotW98170 W1001335 W1001104
ModelOP-2125-8 OP-2125-14 OP-2125-8SLM
Serial numberW98170 W1001335 W1001104
DescriptionOxy2Mask O2/ETCO2
ProductOxy2Pro
LotW1003251
ModelPRM-2110-8F
Serial numberW1003251
DescriptionOxy2Pro
ProductOxy2Mask O2/ETCO2
LotW96157 W1001100 W1001102 W1001332 W1003502
ModelOM-2125-14 OM-2125-8SLM OM-2125-8 OM-2125-14SLM
Serial numberW96157 W1001100 W1001102 W1001332 W1003502
DescriptionOxy2Mask O2/ETCO2
ProductOxy2Mask O2/ETCO2
LotW96158/VAL W1001330
ModelOK-2125-8SLM OK-2125-8
Serial numberW96158/VAL W1001330
DescriptionOxy2Mask O2/ETCO2
ProductOxy2Pro
LotW1001948 W1003244 W99427
ModelPRM-2110-8M
Serial numberW1001948 W1003244 W99427
DescriptionOxy2Pro
ProductOxy2Pro
LotW99426
ModelPRP-2110-8F
Serial numberW99426
DescriptionOxy2Pro
ProductOxy2Pro
LotW1001949
ModelPRP-2110-8M
Serial numberW1001949
DescriptionOxy2Pro

Issue

There is a potential for the elbow component to not be securely connected to the diffuser component. This originated from a complaint received on November 15, 2023. Recall start date: January 5, 2024

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceGeneral public Healthcare Industry
CategoryHealth products - Medical devices - Anaesthesiology
CompaniesSouthmedic Inc. 50 Alliance Blvd, Barrie, Ontario, Canada, L4M 5K3
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-74934
Background{}
CompaniesSouthmedic Inc. 50 Alliance Blvd, Barrie, Ontario, Canada, L4M 5K3
AudiencesGeneral public Healthcare Industry
Source updated2024-01-19

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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