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Recall Observatory FDA recall evidence

Device 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.

Z-1288-2018

October 17, 2017

Class II

Product summary

Firm
Southmedic, Inc.
Event
Event 78568
Status
Terminated
Classification
Class II
Quantity
8,871 cases (25 masks per case) total
Official record key
device-enforcement:Z-1288-2018

Official wording

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

Code information: Part No. (Lot No.); OM-2125-8 (W40056, W40161, W40162, W40317, W40556, W40645, W40668); OK-2125-8 (W37602, W37898, W39852, W40051, W40863); OK-2125-8SLM (W36957, W39164, W39695, W41454); OM-2125-14 (W36512, W38338); OM-2125-14SLM (W35876, W39251, W40873); OM-2125-8 (W36432, W36433, W37099, W37605, W37741, W37742, W37743, W37998, W38477, W38641, W39023, W39850, W40056, W40161, W40162, W40317, W40556, W40645, W40668); OM-2125-8SLM (W36956, W37342, W37488, W37899, W38700, W38905, W39252, W39545, W39546); OM-2325-8(W38340); OP-2125-14 (W37273, W39697); OP-2125-8 (W37031, W38005, W38190, W39027, W39851); OP-2125-8SLM (W37901, W38692, W39253, W41447)

Distribution pattern: US Distribution to the state of California, and Internationally to Canada and Sweden

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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