Reported Aug 4, 2021 · Ongoing
OxyMask O2 Adult REF OM-1125-14
Southmedic, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Southmedic, Inc. · 50 Alliance Blvd · Barrie, N/A · N/A
Is this the product you have?
- OxyMask O2 Adult REF OM-1125-14
- Lot codes and dates
- ModelOM-1125-14
- Lot NumberW73887
- Amount recalled
- 160 cases (25 units per case) in U.S.
Where it was sold
Why it was recalled
Potential for oxygen tubing to disconnect from mask or loosen. Disconnected tubing results in a loss of device function and use of the device could result in inappropriate or a lack of oxygen delivery to the patient.
This product could cause temporary or reversible health problems — stop using it.
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