Reported Apr 11, 2018 · Terminated

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

Southmedic, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Southmedic, Inc. · 50 Alliance Blvd · Barrie, N/A · N/A

Is this the product you have?

  • 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.
Lot codes and dates

12 of 12 products

Products covered by this recall
#Product as published
1Part No. (Lot No.)
2OM-2125-8 (W40056, W40161, W40162, W40317, W40556, W40645, W40668)
3OK-2125-8 (W37602, W37898, W39852, W40051, W40863)
4OK-2125-8SLM (W36957, W39164, W39695, W41454)
5OM-2125-14 (W36512, W38338)
6OM-2125-14SLM (W35876, W39251, W40873)
7OM-2125-8 (W36432, W36433, W37099, W37605, W37741, W37742, W37743, W37998, W38477, W38641, W39023, W39850, W40056, W40161, W40162, W40317, W40556, W40645, W40668)
8OM-2125-8SLM (W36956, W37342, W37488, W37899, W38700, W38905, W39252, W39545, W39546)
9OM-2325-8(W38340)
10OP-2125-14 (W37273, W39697)
11OP-2125-8 (W37031, W38005, W38190, W39027, W39851)
12OP-2125-8SLM (W37901, W38692, W39253, W41447)
Amount recalled
8,871 cases (25 masks per case) total

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 29, 2024 · Data as of Sep 19, 4:51 PM UTC

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