| Class 2 Device Recall Autoject E1 Fixed needle device | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = KZH
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