Recall Z-1288-2018— Southmedic, Inc.
Class II · Terminated
Class II FDA medical device recall by Southmedic, Inc., initiated 2017-10-17, terminated 2024-03-29. It names one FDA 510(k) clearance: K014211. 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.. Reason: Potential for loose or missing CO2 diffusers which could result in a non-functioning mask..
- Recalling firm
- Southmedic, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-10-17
- Terminated
- 2024-03-29
- Firm location
- Barrie, N/A, Canada
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Potential for loose or missing CO2 diffusers which could result in a non-functioning mask.
Data sourced from openFDA. This site is unofficial and independent of the FDA.