Device recall
Z-0206-2018: Dial-A-Dose Insulin Delivery Device (Pen-Injector) cartridge holders Product…
FDA device recall · Class II · Novo Nordisk Inc
Key facts
| Recall number (Z-number) | Z-0206-2018 |
|---|---|
| Recall event | 77704 |
| Product | Dial-A-Dose Insulin Delivery Device (Pen-Injector) cartridge holders Product Usage: The NovoPen Echo is a re-usable pen injector for single patient use by diabetics for the self injection of a desired dose of insulin. The pen injector uses Penfill 3 mL cartridge of NovoLog, 100 units/mL (Ux100)… |
| Product code | FMF |
| Recalling firm | Novo Nordisk Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 9, 2019 |
| 510(k) numbers | K123766, K150874, K162602 |
| FEI number | 2244771 |
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