Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473; Oscillation Lung Expansion Therapy, positive pressure breathing device
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.
Official details
- Category
- Medical device recall
- Status
- Ongoing
- Classification
- Class I
- Company or vendor
- Baxter Healthcare Corporation
- Affected product
- Worldwide distribution - US Nationwide and the country of Canada.
- Risk or reason
- 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.
- Remedy or action
- UDI: 00887761981492; Lot Numbers: All lot numbers distributed beginning on 4/28/2025
- Official ID
- Z-2550-2026