FDA-Device2020-01-01Class I

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

Galemed Corporation
Hazard

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

Sold states
US distribution to distributors in the states of: NC and NV.
Affected count
12000
Manufactured in
87 Wu-Jia, Li-Gong 2nd Road, I-Lan, Taiwan
Products
Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559

Official notice

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

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief