FDA Device recall Z-2093-2014
Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentration partial rebreather, with 7 foot (2.1 m) supply tube, Elastic S…
- FDA Device
- Class II
- terminated
- Published 2014-07-30
On 2014-07-30 the FDA classified a Class II recall of Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentration partial rebreather, with 7 foot (2.1 m) supply tube, Elastic S… by Salter Labs, citing the case label correctly states partial rebreather but the insert label incorrectly states non-rebreather.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2093-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-06-25 |
| Published | 2014-07-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Salter Labs |
| Distribution | US |
Product
Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentration partial rebreather, with 7 foot (2.1 m) supply tube, Elastic Strap Fixation, Single patient use.
Reason
The case label correctly states partial rebreather but the insert label incorrectly states non-rebreather.
Identifiers
| code_info | Lot numbers: 090213, 090913, 021714, 022414, 042814, 051914, 052614 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2093-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.