Hillrom VOLARA System P.CIRCUIT KIT recall
Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expansion Therapy, positive…
Why was Hillrom VOLARA System P.CIRCUIT KIT recalled?
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.
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?
UDI: 00887761985018, Lot Numbers: All lot numbers distributed beginning on 4/28/2025
- Product
- Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expansion Therapy, positive…
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 10540 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Recall date
- July 8, 2026
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)