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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 pr
Recalled July 22, 2015 · FDA recall Z-2082-2015 · Owen Mumford USA
Hazard
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 Class II
Units
225 units
Sold at
Nationwide Distribution including FL, IL, NV, NJ, OH, and TN.
Description
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.
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.
Manufacturer(s)
Owen Mumford USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →