Autopen Classic Automatic insulin delivery pen recalled over sterility concerns

Recall date

December 11, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Owen Mumford USA, Inc. recalls Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01, The prod…

Recall number

Z-2082-2015

FDA classification

Class II

Brand / firm

Owen Mumford USA, Inc.

Sold / distributed

Nationwide Distribution including FL, IL, NV, NJ, OH, and TN.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.