Medical device recalls High risk

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

Recall date
May 30, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0021-2020
FDA classification
Class I
Brand / firm
Galemed Corporation
Sold / distributed
US distribution to distributors in the states of: NC and NV.

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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

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