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

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  Reason
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  Affected products

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