Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01, The produ
FDA device recall Z-2082-2015 · posted 2015-07-15 · Terminated
Recall details
- Recalling firm
- Owen Mumford USA, Inc.
- 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.
- Action taken
- Owen Mumford, Inc. sent an Urgent Medical Device Recall Notification letter dated December 19, 2014, to all affected customers via Fed Ex. The letter instructed customers to check their shelves for the product and specific lot number. The customer was instructed to contact Customer Service to obtain an RMA and a pre-paid, pre-addressed label for return of the devices. A form was included for the documentation of the inspection of their inventory, whether any are in stock and will be returned, and if they will provide a customer list of how they sold any devices to or that they will notify their customers of the issue with the product. They were instructed to fill it out and fax back to 770-977-2866. Customers with questions were instructed to contact Customer Service Department at 1-800-421-6936. For questions regarding this recall call 770-977-2226, ext 13.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FMF
- Quantity affected
- 225 units
- Distribution
- Nationwide Distribution including FL, IL, NV, NJ, OH, and TN.
- Date initiated
- 2014-12-11
- Date posted
- 2015-07-15
- Date terminated
- 2017-07-11
- Location
- Marietta, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OWEN MUMFORD 3ML AUTOPEN (K983974) | Owen Mumford USA, Inc. | 1998-12-21 |