FDA Recalls Autopen Classic Automatic Insulin Delivery Pens Due to Dial Defect
Owen Mumford USA is recalling Autopen Classic Automatic insulin delivery pens because the dose dial fails to stay set, preventing patients from administering their medication.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or those with hospitalization reports, are rated as Severe (4). While no specific injuries are reported in the text, the inability to deliver insulin is a significant health risk that aligns with the upper end of Class II severity.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the Autopen Classic Automatic insulin delivery pen, manufactured by Owen Mumford USA, Inc. The affected product is a non-sterile automatic subcutaneous injection device used to deliver insulin. The recall covers 225 units of the device, specifically Lot 7JH, NDC 08470-3800-01, and UPC Code 384703800014.
The recall was initiated because the dials on the Autopen devices are not functioning correctly. The dial does not stay in the selected position and springs back to 0. As a result, patients are unable to dial up the correct dose of medicine to deliver via injection. This defect prevents the proper administration of insulin.
The affected units were distributed nationwide, including in Florida, Illinois, Nevada, New Jersey, Ohio, and Tennessee. Consumers who possess this specific lot of the Autopen Classic Automatic insulin delivery pen should stop using the device and contact Owen Mumford USA, Inc. for further instructions or a replacement.
The recalled product
- 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
- Owen Mumford USA, Inc.
- Affected units
- 225
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 7JH
- UPC Code 384703800014
Distribution
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