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Southmedic, Inc. recalls OxyMask O2 Adult REF OM-1125-14
Recalled August 4, 2021 · FDA recall Z-2141-2021 · Southmedic
Hazard
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. · FDA Class II
Units
160 cases (25 units per case) in U.S.
Sold at
U.S.: IL O.U.S.: N/A
Description
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.
Product
OxyMask O2 Adult REF OM-1125-14
Manufacturer(s)
Southmedic, Inc.
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →