Baxter Healthcare Corporation: Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expansion Therapy, posit
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- Company / brand
- Baxter Healthcare Corporation
- Product
- Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expansion Therapy, positive pressure breathing device
- Reason / hazard
- 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.
- Classification
- Class I
- Status
- Ongoing
- Distribution / sold at
- Worldwide distribution - US Nationwide and the country of Canada.
- Recall initiated
- 2026-05-21
- Code info
- UDI: 00887761985018, Lot Numbers: All lot numbers distributed beginning on 4/28/2025
- Product quantity
- 10540 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Deerfield
- State
- IL
- Country
- United States
- Event id
- 99119
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