Events

Recall of Device Recall Autoject E1 Fixed needle device

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Owen Mumford USA, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    70665
  • Event Risk Class
    Class 2
  • Event Number
    Z-1366-2015
  • Event Initiated Date
    2014-11-24
  • Event Date Posted
    2015-04-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134363
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Introducer, syringe needle - Product Code KZH
  • 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.

Device

Device Recall Autoject E1 Fixed needle device
  • Model / Serial
    Lot No. 5LW
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US nationwide distribution in the states of AL, AR, CA, FL, GA, IL, MO, NC, OK, TN, and TX.
  • 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.
  • Manufacturer
    Owen Mumford USA, Inc.

Manufacturer

Owen Mumford USA, Inc.
  • Manufacturer Address
    Owen Mumford USA, Inc., 1755 W Oak Commons Ct, Marietta GA 30062-2280
  • Manufacturer Parent Company (2017)
    Owen Mumford Holdings Limited
  • Source
    USFDA