Z-1288-2018Class II

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

Name: Z-1288-2018 Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 masks per case. Minimal contact...
Creator: Southmedic, Inc.
Published: 2017-10-17
License: https://open.fda.gov/license/

Southmedic Inc. / initiated 2017-10-17 / Terminated / root cause: design

FDA source

Southmedic, Inc. began a recall of 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... on 2017-10-17. FDA classified it as Class II and gives the reason as "Potential for loose or missing CO2 diffusers which could result in a non-functioning mask". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1288-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-17
Posted: 2018-01-25
Terminated: 2024-03-29
Recalling firm: Southmedic Inc.
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.
Product code: CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Reason for recall: Potential for loose or missing CO2 diffusers which could result in a non-functioning mask.
Root cause tag: design
FDA root cause: Device Design
Action: Customers were notified via letter on October 17, 2017. Instructions included checking inventory for affected devices and quarantining any found, complete and return the Voluntary Recall Notification Confirmation Form, and arrange for the return of any affected products. On February 14, 2018, the recall was expanded and customers were notified. Instructions were the same as the original notification, but updated the Part/Lot information. For further questions, please call 1 (800) 463-7146
Quantity in commerce: 8,871 cases (25 masks per case) total
Distribution: US Distribution to the state of California, and Internationally to Canada and Sweden
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1288-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1288-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-11	2018-04-02

Product code CCK

K014211Class IIOxyarm CO2Southmedic, Inc. / cleared 2002-06-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)