Device recall
Z-0788-2020: Haylard Closed Suction System for Neonates/Pediatrics, 5 Fr, 1. REF 195…
FDA device recall · Class II · Avanos Medical, Inc.
Key facts
| Recall number (Z-number) | Z-0788-2020 |
|---|---|
| Recall event | 84227 |
| Product | Haylard Closed Suction System for Neonates/Pediatrics, 5 Fr, 1. REF 195, Y-Adapter, SAP Finished Product Code 109382303; 2. REF 201, with BALLARD Technology, SAP Finished Product Code 109382803; 3. REF 202, Elbow, SAP Finished Product Code 109382903; 4. REF 195-5 Y-Adapter, SAP Finished Product Code… |
| Product code | BSY |
| Recalling firm | Avanos Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 16, 2023 |
| 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