Device product
Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
Z-0020-2020
Product summary
- Event
- Event 83318
- Status
- Terminated
- Classification
- Class I
- Quantity
- 2880
- Official record key
device-enforcement:Z-0020-2020
Official wording
Reason: Reports of pressure relief manifold venting gas below the standard pressure.
Code information: UDI: 04710810093562 Lot: 180718, 181204, 190215, and 190610 (Reworked Product)
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.