Recall Z-1366-2015— Owen Mumford USA, Inc.
Class II · Terminated
Class II FDA medical device recall by Owen Mumford USA, Inc., initiated 2014-11-24, terminated 2017-07-31. It names one FDA 510(k) clearance: K945660. 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.. Reason: The syringe carrier is missing components: a damper and spring..
- Recalling firm
- Owen Mumford USA, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-11-24
- Terminated
- 2017-07-31
- Firm location
- Marietta, GA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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 for recall
The syringe carrier is missing components: a damper and spring.
Data sourced from openFDA. This site is unofficial and independent of the FDA.