medical Class I Updated 2020-01-01

Galemed Corporation recalls Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Affected States: NC, NV
Lot/Code Info: UDI: 24710810093559 Lot: 180718, 181107, 181127, 190220, and 190220-190610 (Reworked Product)
View official government recall

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