CLASS II Device recall · Reported 22 Jul 2015 · FDA Enforcement Report
Autopen Classic Automatic insulin delivery pen x 2-, AN3800 recalled
Owen Mumford USA is recalling Autopen Classic Automatic insulin delivery pen x 2-, AN3800, distributed nationwide in the US. The recall was initiated on 11 Dec 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2082-2015
- FDA event ID
- 70783
- Recalling firm
- Owen Mumford USA, Marietta, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Dec 2014
- FDA classified
- 15 Jul 2015
- Reported
- 22 Jul 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 11 Dec 2014 | Recall initiated by company | |
| 15 Jul 2015 | Classified by FDA | +216 days |
| 22 Jul 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Nationwide Distribution including FL, IL, NV, NJ, OH, and TN.
Questions about this recall
Is Autopen Classic Automatic insulin delivery pen x 2-, AN3800 recalled?
Yes. Owen Mumford USA recalled Autopen Classic Automatic insulin delivery pen x 2-, AN3800 on 11 Dec 2014. The recall is Class II and its status is Terminated. Recall number Z-2082-2015.
Why was it 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.
Which lots are affected?
Lot 7JH, UPC Code 384703800014
Where was it sold?
Nationwide Distribution including FL, IL, NV, NJ, OH, and TN.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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