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U.S. Department of Health and Human Services

Class 2 Device Recall Autoject E1 Fixed needle device

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  Class 2 Device Recall Autoject E1 Fixed needle device see related information
Date Initiated by Firm November 24, 2014
Date Posted April 02, 2015
Recall Status1 Terminated 3 on July 31, 2017
Recall Number Z-1366-2015
Recall Event ID 70665
510(K)Number K945660  
Product Classification Introducer, syringe needle - Product Code KZH
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.
Code Information Lot No. 5LW
Recalling Firm/
Manufacturer		 Owen Mumford USA, Inc.
1755 W Oak Commons Ct
Marietta GA 30062-2280
For Additional Information Contact Travis Shaw
770-977-2226
Manufacturer Reason
for Recall		 The syringe carrier is missing components: a damper and spring.
FDA Determined
Cause 2		 Process control
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.
Quantity in Commerce 3,100
Distribution US nationwide distribution in the states of AL, AR, CA, FL, GA, IL, MO, NC, OK, TN, and TX.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KZH and Original Applicant = OWEN MUMFORD USA, INC.
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