FDA-Device2015-07-22Class II
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.
Owen Mumford USA, Inc.
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.
Sold states
Nationwide Distribution including FL, IL, NV, NJ, OH, and TN.
Affected count
225 units
Manufactured in
1755 W Oak Commons Ct, N/A, Marietta, GA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2082-2015Don't want to check this manually?
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