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.
FDA Recall Z-1288-2018 · Posted 2018-01-25
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Recalling FirmSouthmedic, Inc.
Recall StatusTerminated
Product CodeCCK
Date Initiated2017-10-17
Date Terminated2024-03-29
Product Quantity8,871 cases (25 masks per case) total
Reason for Recall
Potential for loose or missing CO2 diffusers which could result in a non-functioning mask.
Firm 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
Root Cause
Device Design
Distribution Pattern
US Distribution to the state of California, and Internationally to Canada and Sweden
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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