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U.S. Department of Health and Human Services

Class 2 Device Recall Autoject EI

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  Class 2 Device Recall Autoject EI see related information
Date Initiated by Firm July 17, 2019
Create Date November 01, 2019
Recall Status1 Open3, Classified
Recall Number Z-0263-2020
Recall Event ID 83465
510(K)Number K945660  
Product Classification Introducer, syringe needle - Product Code KZH
Product Autoject EI, REF AJ1310
Code Information Lot/Unit Number: V14
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 Ext. 12
Manufacturer Reason
for Recall		 There is a possible assembly error on Autoject EI, lot number V14. This lot was packed into two products: AJ 1310, lot number V14 and AN 3310VET (branded as Petfine Auto Injector), batches V14.V976 & V14.W107
FDA Determined
Cause 2		 Employee error
Action The firm initiated the recall by letter on 07/17/2019. The consignee was directed to quarantine all affected product and contact the company for return. Distributors were also directed to cease distribution and contact their customers.
Quantity in Commerce 1510 units
Distribution FL, LA, SC, CA, NJ, TX, NC, CO, NH, KY, NY, MO, PA
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = KZH and Original Applicant = OWEN MUMFORD USA, INC.
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