Medical device recalls Moderate risk

Southmedic, Inc. recalls Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 masks per case. Minimal contact, open oxygen…

Recall date
October 17, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1288-2018
FDA classification
Class II
Brand / firm
Southmedic, Inc.
Sold / distributed
US Distribution to the state of California, and Internationally to Canada and Sweden

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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