Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Number: M08594A Software Version: N/A Product Description: VOLARA, H…
Baxter Healthcare Corporation · Contamination within the release test equipment flow path could have affected the accuracy of the nebulizer flow rate. Affected devices returned to firm and te…
Open FDA's page for this record- Cfres ID
- 222192
- Product res number
- Z-3257-2026
- Event date initiated
- 2026-08-03
- Event date posted
- 2026-09-23
- Recall status
- Open, Classified
- Res event number
- 99681
- Product code
- NHJ
- Code info
- Lot Code: UDI: 00887761981690 Serial Numbers: W078SY3553 and Z309SY7853
- Firm FEI number
- 1417572
- Recalling firm
- Baxter Healthcare Corporation
- Address 1
- 1 Baxter Pkwy
- City
- Deerfield
- State
- IL
- Postal code
- 60015-4625
- Additional info contact
- Center for One Baxter 1-847-9484770
- Root cause description
- Device Design
- Product quantity
- 2
- Distribution pattern
- US Nationwide distribution in the states of Colorado and Florida.
- Product description
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.
- Action
Affected consignees were notified by phone on August 3, 2026. Customers were informed that as a precaution, Baxter would replace impacted VOLARA devices. A Baxter clinical trainer would contact the customers to schedule a home visit to exchange the device. Customers were asked to continue to use the VOLARA device as prescribed until it was exchanged. As of August 13, 2026, all potentially affected devices have been returned to Baxter.
- K numbers
- K200988
- Harmonized identifiers (openFDA)
- Device name
- Device, Positive Pressure Breathing, Intermittent
- Medical specialty description
- Anesthesiology
- Regulation number
- 868.5905
- Device class
- 2
- K number
- K924174, K213564, K781232, K231728, K253001, K121955, K002598, K124032, K981726, K072292, K051964, K895485, K140598, K242438, K113549, K003684, K132988, K151689, K191912, K192143, K140605, K982016, K120277, K260604, K200988, K905236
- Registration number
- 3006446479, 2183816, 3016774528, 3023272766, 2518422, 2951529, 3008145987, 3029845, 3008700378, 3004050971, 3029227324, 3007123976, 3010817335, 3021244152, 3011120183, 9617566, 3017373426, 1000604079, 3013095415, 3010834934, 3006087789, 3017520736, 3000126629, 3006240053, 3009987158, 3006534321, 3003589956, 3018783526, 3020562909
- FEI number
- 3006446479, 2183816, 3016774528, 3023272766, 2518422, 3008145987, 3003244771, 3008700378, 3004050971, 3029227324, 3007123976, 3010817335, 3021244152, 3011120183, 3017373426, 1000604079, 1000524541, 3013095415, 3010834934, 1000307109, 3006087789, 3017520736, 3000126629, 3006240053, 3009987158, 3006534321, 3003589956, 3018783526, 3020562909