SeriousFDAOngoing
Can cause serious illness or death. Do not eat it.
Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; Oscillation Lung Expansion Therapy, positive pressure breathing device
Check your package for
UDI: 10887761985015; Lot Numbers: All lot numbers distributed beginning on 4/28/2025
- Why
- 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.
- Distributed
- Worldwide distribution - US Nationwide and the country of Canada.
- Company
- Baxter Healthcare Corporation
- Announced
- Recall began