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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 devicesee related information
Date Initiated by FirmNovember 24, 2014
Date PostedApril 02, 2015
Recall Status1 Terminated 3 on July 31, 2017
Recall NumberZ-1366-2015
Recall Event ID 70665
510(K)NumberK945660 
Product Classification Introducer, syringe needle - Product Code KZH
ProductAutoject 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 ContactTravis Shaw
770-977-2226
Manufacturer Reason
for Recall
The syringe carrier is missing components: a damper and spring.
FDA Determined
Cause 2
Process control
ActionRecall 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 Commerce3,100
DistributionUS nationwide distribution in the states of AL, AR, CA, FL, GA, IL, MO, NC, OK, TN, and TX.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KZH
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