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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