Drug recall
Autoject E1 Fixed needle device, Model Number AJ1310, UPC Code 384701310010 The Autoject E1 is an injector…
FDA recall event 70665 · Class II · Owen Mumford USA, Inc.
Key facts
| Event ID | 70665 |
|---|---|
| Recall numbers | Z-1366-2015 |
| Recalling firm | Owen Mumford USA, Inc. |
| Product type | Devices |
| Products | 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. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The syringe carrier is missing components: a damper and spring. |
| Initiation date | Nov 24, 2014 |
| Report date | Apr 8, 2015 |
| Termination date | Jul 31, 2017 |
| City | Marietta |
| State | GA |
| Country | United States |
| FEI number | 1000219614 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: