FDAClass IJanuary 1, 2020

Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas recall

Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802

Why was Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas 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: 04710810100802 Lot: 180806, 180910, 181029, 181105, 181204, 190225, 190327

Product
Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802
Recalling firm
Galemed Corporation
Quantity
14964
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)
Open FDA enforcement record Latest recalls