Recall Z-0206-2018 ยท FMF Syringe, Piston
Novo Nordisk Inc
Dial-A-Dose Insulin Delivery Device (Pen-Injector) cartridge holders Product Usage: The NovoPen Echo is a re-usable pen injector for single patient use by diabetics for the self injection of a desired dose of insulin. The pen injector uses Penfill 3 mL cartridge of NovoLog, 100 units/mL (Ux100) [insulin aspart (rDNA origin) injection] and a single use detachable and disposable pen needle (supplie
| Date | Jul 5, 2017 |
| Status | Terminated |
| Reason | A small number of batches may crack or break if exposed to certain chemicals, like certain cleaning agents. |
| Root cause | Device Design |
| Action | Novo Nordisk a Urgent Medical Device Letter dated July 10, 2017 to customers. The letter identified the affected product, problem and actions to be taken. In the United States, customers with diabetes using a NovoPen Echo from one of the affected batches listed are instructed to call Novo Nordisk at 1-855-419-8827 between 8 am and 6 pm EDT to get a replacement cartridge holder. For questions specific to the recall, please call 1-855-419-8827. If you have any other general questions or concerns, please contact Novo Nordisk Customer Care at 1-800-727-6500, Monday-Friday, 8:30 am 6 pm EDT. |
| Quantity | 16,557 units |
| Distribution | Nationwide distribution |
| FDA record | Open on fda.gov |