FDA recall Z-0021-2020

Galemed Corporation · Class I · device

Product

Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559

Reason for recall

Reports of pressure relief manifold venting gas below the standard pressure.

Distribution

US distribution to distributors in the states of: NC and NV.

Key facts

Status
Terminated
Initiation date
2019-05-30
Report date
2020-01-01
Termination date
2024-05-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
I-Lan, Taiwan

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0021-2020