Baxter Healthcare Corporation — Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473; Oscillation Lung Expansion Therapy, positive pressure breathing de
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- May 21, 2026
Worldwide distribution - US Nationwide and the country of Canada.
What's affected?
- Product
- Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473; Oscillation Lung Expansion Therapy, positive pressure breathing device
- Lot code
- All
Additional details
UDI: 00887761981492; Lot Numbers: All lot numbers distributed beginning on 4/28/2025
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: 16187 units.
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