Southmedic, Inc. recalls OxyMask O2 Adult REF OM-1125-14

Recall date

May 25, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2141-2021

FDA classification

Class II

Brand / firm

Southmedic, Inc.

Sold / distributed

U.S.: IL O.U.S.: N/A

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

OxyMask O2 Adult REF OM-1125-14