Device recall
Z-0025-2020: Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
FDA device recall · Class II · AURIS HEALTH INC
Key facts
| Recall number (Z-number) | Z-0025-2020 |
|---|---|
| Recall event | 82763 |
| Product | Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120 |
| Product code | EOQ |
| Recalling firm | AURIS HEALTH INC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 19, 2022 |
| 510(k) numbers | K173760 |
| FEI number | 3014447948 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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