Device recall
Z-2082-2015: Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units…
FDA device recall · Class II · Owen Mumford USA, Inc.
Key facts
| Recall number (Z-number) | Z-2082-2015 |
|---|---|
| Recall event | 70783 |
| Product | Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01, The product is a non-sterile automatic subcutaneous injection device which delivers insulin. |
| Product code | FMF |
| Recalling firm | Owen Mumford USA, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 11, 2017 |
| 510(k) numbers | K983974 |
| FEI number | 1000219614 |
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