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Southmedic, Inc. recalls Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 masks per case. Minimal contact, open oxyg
Recalled April 11, 2018 · FDA recall Z-1288-2018 · Southmedic
Hazard
Potential for loose or missing CO2 diffusers which could result in a non-functioning mask. · FDA Class II
Units
8,871 cases (25 masks per case) total
Sold at
US Distribution to the state of California, and Internationally to Canada and Sweden
Description
Potential for loose or missing CO2 diffusers which could result in a non-functioning mask.
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.
Manufacturer(s)
Southmedic, Inc.
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →