Home / Recalls / Owen Mumford USA, Inc. / Z-1366-2015

Z-1366-2015 Class II Terminated

Recalled by Owen Mumford USA, Inc. — Marietta, GA

Recall Details

Product Type
Devices
Report Date
April 8, 2015
Initiation Date
November 24, 2014
Termination Date
July 31, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3,100

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.

Distribution Pattern

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

Code Information

Lot No. 5LW

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  • Z-0263-2020 Class II — Autoject EI, REF AJ1310 (July 17, 2019)
  • Z-0381-2018 Class II — Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles. Produc (November 6, 2017)
  • Z-0382-2018 Class II — Unifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles. Produc (November 6, 2017)
  • Z-2082-2015 Class II — Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN380 (December 11, 2014)