Class 2 Device Recall Autopen Classic

• Date Initiated by Firm: December 11, 2014
• Date Posted: July 15, 2015
• Recall Status: Terminated on July 11, 2017
• Recall Number: Z-2082-2015
• Recall Event ID: 70783
• 510(K)Number: K983974
• Product Classification: Syringe, piston - Product Code FMF
• Product: Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01, The product is a non-sterile automatic subcutaneous injection device which delivers insulin.
• Code Information: Lot 7JH, UPC Code 384703800014
• FEI Number: 1000219614
• 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: The dials in the Autopens are not working - the dial does not stay dialed, but springs right back to 0. As a result, the patient could not dial up a dose of medicine to deliver via an injection.
• FDA Determined Cause: Process control
• Action: Owen Mumford, Inc. sent an Urgent Medical Device Recall Notification letter dated December 19, 2014, to all affected customers via Fed Ex. The letter instructed customers to check their shelves for the product and specific lot number. The customer was instructed to contact Customer Service to obtain an RMA and a pre-paid, pre-addressed label for return of the devices. A form was included for the documentation of the inspection of their inventory, whether any are in stock and will be returned, and if they will provide a customer list of how they sold any devices to or that they will notify their customers of the issue with the product. They were instructed to fill it out and fax back to 770-977-2866. Customers with questions were instructed to contact Customer Service Department at 1-800-421-6936. For questions regarding this recall call 770-977-2226, ext 13.
• Quantity in Commerce: 225 units
• Distribution: Nationwide Distribution including FL, IL, NV, NJ, OH, and TN.
• 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 = FMF