Device recall
Z-1366-2015: Autoject E1 Fixed needle device, Model Number AJ1310, UPC Code 384701310010 The…
FDA device recall · Class II · Owen Mumford USA, Inc.
Key facts
| Recall number (Z-number) | Z-1366-2015 |
|---|---|
| Recall event | 70665 |
| Product | Autoject E1 Fixed needle device, Model Number AJ1310, UPC Code 384701310010 The Autoject E1 is an injector used by patients to inject drugs as prescribed by their doctor. |
| Product code | KZH |
| Recalling firm | Owen Mumford USA, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 31, 2017 |
| 510(k) numbers | K945660 |
| FEI number | 1000219614 |
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