FDA recall Z-1288-2018

Southmedic, Inc. · Class II · device

Product

Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 masks per case. Minimal contact, open oxygen delivery device for use with USP medical grade oxygen and for monitoring breathing by providing a means to sample exhaled CO2.

Reason for recall

Potential for loose or missing CO2 diffusers which could result in a non-functioning mask.

Distribution

US Distribution to the state of California, and Internationally to Canada and Sweden

Key facts

Status
Terminated
Initiation date
2017-10-17
Report date
2018-04-11
Termination date
2024-03-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Barrie, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1288-2018