FDA-Device2018-04-11Class II
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.
Southmedic, Inc.
Hazard
Potential for loose or missing CO2 diffusers which could result in a non-functioning mask.
Sold states
US Distribution to the state of California, and Internationally to Canada and Sweden
Affected count
8,871 cases (25 masks per case) total
Manufactured in
50 Alliance Blvd, N/A, Barrie, N/A, Canada
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1288-2018Don't want to check this manually?
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