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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