Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure recall
Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
Why was Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure recalled?
Reports of pressure relief manifold venting gas below the standard pressure.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: 24710810093559 Lot: 180718, 181107, 181127, 190220, and 190220-190610 (Reworked Product)
- Product
- Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
- Recalling firm
- Galemed Corporation
- Quantity
- 12000
- Distribution
- US distribution to distributors in the states of: NC and NV.
- Recall date
- January 1, 2020
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)