Device product
Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
Z-0021-2020
Product summary
- Event
- Event 83318
- Status
- Terminated
- Classification
- Class I
- Quantity
- 12000
- Official record key
device-enforcement:Z-0021-2020
Official wording
Reason: Reports of pressure relief manifold venting gas below the standard pressure.
Code information: UDI: 24710810093559 Lot: 180718, 181107, 181127, 190220, and 190220-190610 (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.