Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 0...
FDA Recall #Z-2082-2015 — Class II — December 11, 2014
Product Description
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.
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.
Recalling Firm
Owen Mumford USA, Inc. — Marietta, GA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
225 units
Distribution
Nationwide Distribution including FL, IL, NV, NJ, OH, and TN.
Code Information
Lot 7JH, UPC Code 384703800014
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated