Class IIDeviceOngoing

Baxter Healthcare Corporation

Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Number: M08594A Software Version: N/A Product Description: VOLARA, HOMECARE, NORTH AMERICA Component: No

Reason for recall

Contamination within the release test equipment flow path could have affected the accuracy of the nebulizer flow rate. Affected devices returned to firm and testing confirmed devices meet specifications.

Details

Recall number: Z-3257-2026
Event ID: 99681
Recall initiated: Aug 3, 2026
Classified: Sep 23, 2026
Reported: Sep 30, 2026
Quantity: 2
Distribution: US Nationwide distribution in the states of Colorado and Florida.
Initiated by: Voluntary: Firm initiated
Firm notification: Telephone
Firm location: Deerfield, IL, United States
Lot / code info: Lot Code: UDI: 00887761981690 Serial Numbers: W078SY3553 and Z309SY7853