FDA-Device2021-08-04Class II
OxyMask O2 Adult REF OM-1125-14
Southmedic, Inc.
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.
Sold states
U.S.: IL O.U.S.: N/A
Affected count
160 cases (25 units per case) in U.S.
Manufactured in
50 Alliance Blvd, N/A, Barrie, N/A, Canada
Products
OxyMask O2 Adult REF OM-1125-14
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2141-2021Don't want to check this manually?
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