FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corporation: Volara System. Blue Ventilator Adapter Module. Intermittent positive pressure breathing device component.
- Recall number
- Z-2322-2024
- Recalling firm
- Baxter Healthcare Corporation
- Product
- Volara System. Blue Ventilator Adapter Module. Intermittent positive pressure breathing device component.
- Status
- Open, Classified
- Initiated
- 2024-05-30
- Posted
- 2024-07-17
- Terminated
- not on file
- Reason
- Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow.
- Root cause
- Device Design
- Action
- Baxter Healthcare notified customers on about 05/30/2024 via letter sent first-class mail. The letter instructed facilities to immediately locate, isolate, and cease all use of the affected lot numbers, return affected units on hand, and complete and return the acknowledgement form. If the product was further distributed, they were instructed to notify customers if product was further distributed. The letter instructed patients to immediately locate, isolate, and cease all use of the affected lot numbers, return affected units on hand, however if they do not have other options in stock, in order to not delay therapy, you may continue to use with caution. Visually inspect the nebulizer port prior to therapy and assess for ventilator gas flow leaks for the duration of therapy. They were also instructed to complete and return the acknowledgement form.
- Quantity
- 350 units
- Distribution
- Nationwide distribution. International distribution to Canada, France, and Germany.
- Lot, serial or model codes
- Product Code: M07937; Lot numbers: 4210495, 4325617.
- 510(k) numbers
- ["K192143","K200988"]
- PMA numbers
- not on file
- Product code
- NHJ
- Firm FEI
- 1417572
- Firm city
- Deerfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28