Galemed Corporation recalls Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 047…
- Recall date
- May 30, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0022-2020
- 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 with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802
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