Recall Z-2082-2015 ยท FMF Syringe, Piston
Owen Mumford USA, Inc.
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.
| Date | Jul 15, 2015 (initiated Dec 11, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | 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 th |
| Quantity | 225 units |
| Distribution | Nationwide Distribution including FL, IL, NV, NJ, OH, and TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983974 | OWEN MUMFORD 3ML AUTOPEN Owen Mumford USA, Inc., Dec 21, 1998 |