Recall Z-1288-2018 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Southmedic, Inc.
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.
| Date | Jan 25, 2018 (initiated Oct 17, 2017) |
| Status | Terminated |
| Reason | Potential for loose or missing CO2 diffusers which could result in a non-functioning mask. |
| 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 | 8,871 cases (25 masks per case) total |
| Distribution | US Distribution to the state of California, and Internationally to Canada and Sweden |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K014211 | OXYARM CO2 Southmedic, Inc., Jun 11, 2002 |