Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 masks per case. Minimal contact, open oxygen
FDA device recall Z-1288-2018 · posted 2018-01-25 · Terminated
Recall details
- Recalling firm
- Southmedic, Inc.
- Reason for recall
- Potential for loose or missing CO2 diffusers which could result in a non-functioning mask.
- Action taken
- 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
- Status
- Terminated
- Product code
- CCK
- Quantity affected
- 8,871 cases (25 masks per case) total
- Distribution
- US Distribution to the state of California, and Internationally to Canada and Sweden
- Date initiated
- 2017-10-17
- Date posted
- 2018-01-25
- Date terminated
- 2024-03-29
- Location
- Barrie, Canada
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OXYARM CO2 (K014211) | Southmedic, Inc. | 2002-06-11 |