Devices

Device Recall Autopen Classic

Model / Serial
Lot 7JH, UPC Code 384703800014
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution including FL, IL, NV, NJ, OH, and TN.
Product Description
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
Owen Mumford USA, Inc.
1 Event
- Recall of Device Recall Autopen Classic

Manufacturer

Owen Mumford USA, Inc.

Manufacturer Address
Owen Mumford USA, Inc., 1755 W Oak Commons Ct, Marietta GA 30062-2280
Manufacturer Parent Company (2017)
Owen Mumford Holdings Limited
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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