FDA Device recall Z-1190-2023
BALLARD* ACCESS Closed Suction System for Neonates/Pediatrics, Elbow Manifold
- FDA Device
- Class I
- terminated
- Published 2023-03-22
On 2023-03-22 the FDA classified a Class I recall of BALLARD* ACCESS Closed Suction System for Neonates/Pediatrics, Elbow Manifold by Avanos Medical, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1190-2023 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2023-02-03 |
| Published | 2023-03-22 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Avanos Medical |
| Distribution | US |
Product
BALLARD* ACCESS Closed Suction System for Neonates/Pediatrics, Elbow Manifold.
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.
Identifiers
| code_info | All lots are affected. Stock Code (Lot Number): B50511 (20098277), B50611 (20098278), B50711 (20098279), B50811 (20097177, 20097177R1). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1190-2023%22
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