Autoject E1 Fixed needle device, Model Number AJ1310, UPC Code 384701310010 The Autoject E1 is an injector used by patie
FDA device recall Z-1366-2015 · posted 2015-04-02 · Terminated
Recall details
- Recalling firm
- Owen Mumford USA, Inc.
- Reason for recall
- The syringe carrier is missing components: a damper and spring.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KZH
- Quantity affected
- 3,100
- Distribution
- US nationwide distribution in the states of AL, AR, CA, FL, GA, IL, MO, NC, OK, TN, and TX.
- Date initiated
- 2014-11-24
- Date posted
- 2015-04-02
- Date terminated
- 2017-07-31
- Location
- Marietta, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AUTOJECT 2 (K945660) | Owen Mumford USA, Inc. | 1995-08-11 |