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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