BALLARD* ACCESS Closed Suction System for Neonates/Pediatrics — Class I medical device recall Z-1190-2023
Terminated recall by Avanos Medical, Inc., reported 2023-03-22, distributed nationwide. Potential for product manifold to crack during use on patients, possibly causing leaks in the respiratory circ
| Recall number | Z-1190-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Avanos Medical, Inc., Alpharetta, GA, United States |
| Recall initiated | 2023-02-03 |
| Classified | 2023-03-13 |
| Reported by FDA | 2023-03-22 |
| Terminated | 2024-09-05 |
| Distributed | Nationwide (US) |
| Quantity | 220 units |
| Reason classes | packaging |
| Lot numbers | B50511, B50611, B50711, B50811 |
Product
BALLARD* ACCESS Closed Suction System for Neonates/Pediatrics, Elbow Manifold.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1190-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.