FDA recall Z-2141-2021

Southmedic, Inc. · Class II · device

Product

OxyMask O2 Adult REF OM-1125-14

Reason for recall

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.

Distribution

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

Key facts

Status: Ongoing
Initiation date: 2021-05-25
Report date: 2021-08-04
Voluntary/Mandated: Voluntary: Firm initiated
Location: Barrie, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2141-2021