FDA recall Z-0020-2020

Galemed Corporation · Class I · device

Product

Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562

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-0020-2020