Device recall
Z-2553-2019: Gold Cup Leadwire and Snap Leadwire with the following component descriptions…
FDA device recall · Class II · GN Otometrics
Key facts
| Recall number (Z-number) | Z-2553-2019 |
|---|---|
| Recall event | 83491 |
| Product | Gold Cup Leadwire and Snap Leadwire with the following component descriptions: 1. 24" Snap Leadwire, Blue; 2. 40" Snap Leadwire, Blue; 3. 24" Snap Leadwire, Red; 4. 40" Snap Leadwire, Red; 5. 24" Snap Leadwire, Green; 6. 40" Snap Leadwire, Green; 7. 24" Snap Leadwire, Brown; 8. 40" Snap Leadwire… |
| Product code | DSA |
| Recalling firm | GN Otometrics |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K080112 |
| FEI number | 3002807554 |
At a glance
- 1–9 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