Skip to content
Recall Observatory FDA recall evidence

Device 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.

Z-1366-2015

November 24, 2014

Class II

Product summary

Firm
Owen Mumford USA, Inc.
Event
Event 70665
Status
Terminated
Classification
Class II
Quantity
3,100
Official record key
device-enforcement:Z-1366-2015

Official wording

Reason: The syringe carrier is missing components: a damper and spring.

Code information: Lot No. 5LW

Distribution pattern: US nationwide distribution in the states of AL, AR, CA, FL, GA, IL, MO, NC, OK, TN, and TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The syringe carrier is missing components: a damper and spring.