Baxter Healthcare Corporation: Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; Oscillation Lung Expansion Therapy, posi
Read the official notice at FDA (device) →
Get alerts for Baxter Healthcare
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Baxter Healthcare Corporation
- Product
- Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; 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: 10887761985015; Lot Numbers: All lot numbers distributed beginning on 4/28/2025
- Product quantity
- 0
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Deerfield
- State
- IL
- Country
- United States
- Event id
- 99119
Free daily digest + "My products" watchlist