Device recall
Z-1189-2023: BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold.
FDA device recall · Class I · Avanos Medical, Inc.
Key facts
| Recall number (Z-number) | Z-1189-2023 |
|---|---|
| Recall event | 91663 |
| Product | BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold. |
| Product code | BSY |
| Recalling firm | Avanos Medical, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Sep 5, 2024 |
| FEI number | 3011270181 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database