Reported Jul 22, 2015 · Terminated
Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01, The…
Owen Mumford USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Owen Mumford USA, Inc. · 1755 W Oak Commons Ct · Marietta, GA · 30062-2280
Is this the product you have?
- 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.
- Lot codes and dates
Lot 7JHUPC Code 384703800014
- Amount recalled
- 225 units
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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