FDA Recall
Terminated
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.
Recall: Z-1366-2015
·
Initiated November 24, 2014
Recall
- Recall Number
- Z-1366-2015
- Event Number
- 70665
- Firm
- Owen Mumford USA, Inc.
- FEI Number
- 1000219614
- Product Code
- KZH
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- November 24, 2014
- Posted
- April 2, 2015
- Terminated
- July 31, 2017
- Address
- 1755 W Oak Commons Ct, Marietta, GA, 30062-2280
Description
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.
Reason
The syringe carrier is missing components: a damper and spring.
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.
Distribution
US nationwide distribution in the states of AL, AR, CA, FL, GA, IL, MO, NC, OK, TN, and TX.
Quantity
3,100