Medical device recalls High risk

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

Recall date
May 30, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0020-2020
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 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562

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