Device product
Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802
Z-0022-2020
Product summary
- Event
- Event 83318
- Status
- Terminated
- Classification
- Class I
- Quantity
- 14964
- Official record key
device-enforcement:Z-0022-2020
Official wording
Reason: Reports of pressure relief manifold venting gas below the standard pressure.
Code information: UDI: 04710810100802 Lot: 180806, 180910, 181029, 181105, 181204, 190225, 190327
Distribution pattern: US distribution to distributors in the states of: NC and NV.
Derived failure modes
-
Unknown
Reports of pressure relief manifold venting gas below the standard pressure.