FDAClass IJuly 24, 2024

Volara System. Blue Ventilator Adapter Module. recall

Volara System. Blue Ventilator Adapter Module. Intermittent positive pressure breathing device component.

Why was Volara System. Blue Ventilator Adapter Module. recalled?

Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

Product Code: M07937; Lot numbers: 4210495, 4325617.

Product
Volara System. Blue Ventilator Adapter Module. Intermittent positive pressure breathing device component.
Recalling firm
Baxter Healthcare Corporation
Quantity
350 units
Distribution
Nationwide distribution. International distribution to Canada, France, and Germany.
Recall date
July 24, 2024
Classification
Class I
Status
Ongoing
Agency
FDA (device)
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