Reported Jan 1, 2020 · Terminated
Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
Galemed Corporation
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Galemed Corporation · 87 Wu-Jia · I-Lan · N/A
Is this the product you have?
- Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only
- UDI24710810093559
- Lot codes and dates
- UDI24710810093559
- Lot
180718181107181127190220and 190220-190610 (Reworked Product)
- Amount recalled
- 12000
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Stop using this product now
Reports of pressure relief manifold venting gas below the standard pressure.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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