CLASS I Device recall · Reported 1 Jan 2020 · FDA Enforcement Report
Babi.Plus Bubble PAP Valve with H2O Pressure Relief Manifold recalled
Galemed is recalling Babi.Plus Bubble PAP Valve with H2O Pressure Relief Manifold, distributed in North Carolina, Nevada. The recall was initiated on 30 May 2019 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0021-2020
- FDA event ID
- 83318
- Recalling firm
- Galemed, I-Lan
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 30 May 2019
- FDA classified
- 20 Dec 2019
- Reported
- 1 Jan 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 30 May 2019 | Recall initiated by company | |
| 20 Dec 2019 | Classified by FDA | +204 days |
| 1 Jan 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Reports of pressure relief manifold venting gas below the standard pressure.
Product as listed by the FDA
Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
Where it was distributed
US distribution to distributors in the states of: NC and NV.
Questions about this recall
Is Babi.Plus Bubble PAP Valve with H2O Pressure Relief Manifold recalled?
Yes. Galemed recalled Babi.Plus Bubble PAP Valve with H2O Pressure Relief Manifold on 30 May 2019. The recall is Class I and its status is Terminated. Recall number Z-0021-2020.
Why was it recalled?
Reports of pressure relief manifold venting gas below the standard pressure.
Which lots are affected?
UDI: 24710810093559 Lot: 180718, 181107, 181127, 190220, and 190220-190610 (Reworked Product)
Where was it sold?
US distribution to distributors in the states of: NC and NV.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Galemed
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Babi.Plus H2O Pressure Relief Manifold recalled by Galemed | Galemed | Device Malfunction | NC, NV |
| Device | CLASS I | Babi.Plus H2O Pressure Relief Manifold recalled by Galemed | Galemed | Other | NC, NV |
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