Recall Z-1366-2015 ยท KZH Introducer, Syringe Needle
Owen Mumford USA, Inc.
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.
| Date | Apr 2, 2015 (initiated Nov 24, 2014) |
| Status | Terminated |
| Reason | The syringe carrier is missing components: a damper and spring. |
| Root cause | Process control |
| Action | Recall letters were issued to customers via FedEx. The letter instructed the customer to check their shelves for the product and specific lot number and to visually inspect (pictures included in letter of a correctly assembled device and one with the missing spring & damper) the device if they have the affected lot. A form was included which was to be filed out and returned. |
| Quantity | 3,100 |
| Distribution | US nationwide distribution in the states of AL, AR, CA, FL, GA, IL, MO, NC, OK, TN, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K945660 | AUTOJECT 2 Owen Mumford USA, Inc., Aug 11, 1995 |