FDA Medical Device Recalls (openFDA)
Avanos Medical, Inc.: BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold.
- Recall number
- Z-1189-2023
- Recalling firm
- Avanos Medical, Inc.
- Product
- BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold.
- Status
- Terminated
- Initiated
- 2023-02-03
- Posted
- 2023-03-13
- Terminated
- 2024-09-05
- Reason
- Potential for product manifold to crack during use on patients, possibly causing leaks in the respiratory circuit and can lead to the patient receiving inadequate ventilation.
- Root cause
- Component design/selection
- Action
- Avanos hand-delivered the recall notification to the single consignee on 02/03/2023. The letter instructed the customer to discontinue use of and quarantine their stock of all lots of affected units and return them. Additionally, the customer was instructed to complete and return the acknowledgement form.
- Quantity
- 780 units
- Distribution
- US Nationwide distribution in the state of Oklahoma.
- Lot, serial or model codes
- All lots are affected. Stock Code (Lot Number): B30511 (20098360), B30611 (20098361), B30711 (20097200), B30811 (20098362), B31011 (20098363).
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BSY
- Firm FEI
- 3011270181
- Firm city
- Alpharetta
- Firm state
- GA
- 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