FDA-Device2020-01-01Class I

Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802

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
14964
Manufactured in
87 Wu-Jia, Li-Gong 2nd Road, I-Lan, Taiwan
Products
Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0022-2020

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