FDA (Device enforcement)Recalled 2026-08-03class ii

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 Compone

Is my product affected?

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

UPC 00887761981690

Check against the official notice below — it lists the full affected range.

Hazard

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 from the source

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. Distribution: US Nationwide distribution in the states of Colorado and Florida. Quantity: 2 Lot/code info: Lot Code: UDI: 00887761981690 Serial Numbers: W078SY3553 and Z309SY7853

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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