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 1 Part No. (Lot No.) 2 OM-2125-8 (W40056, W40161, W40162, W40317, W40556, W40645, W40668) 3 OK-2125-8 (W37602, W37898, W39852, W40051, W40863) 4 OK-2125-8SLM (W36957, W39164, W39695, W41454) 5 OM-2125-14 (W36512, W38338) 6 OM-2125-14SLM (W35876, W39251, W40873) 7 OM-2125-8 (W36432, W36433, W37099, W37605, W37741, W37742, W37743, W37998, W38477, W38641, W39023, W39850, W40056, W40161, W40162, W40317, W40556, W40645, W40668) 8 OM-2125-8SLM (W36956, W37342, W37488, W37899, W38700, W38905, W39252, W39545, W39546) 9 OM-2325-8(W38340) 10 OP-2125-14 (W37273, W39697) 11 OP-2125-8 (W37031, W38005, W38190, W39027, W39851) 12 OP-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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