FDA Device recall Z-0022-2020
Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802
- FDA Device
- Class I
- terminated
- Published 2020-01-01
On 2020-01-01 the FDA classified a Class I recall of Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802 by Galemed, citing reports of pressure relief manifold venting gas below the standard pressure.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0022-2020 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2019-05-30 |
| Published | 2020-01-01 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Galemed |
| Distribution | NC, NV |
Product
Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802
Reason
Reports of pressure relief manifold venting gas below the standard pressure.
Identifiers
| code_info | UDI: 04710810100802 Lot: 180806, 180910, 181029, 181105, 181204, 190225, 190327 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0022-2020%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.