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 (supplied separately). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in 0.5 increments.
Recall
- Recall Number
- Z-0206-2018
- Event Number
- 77704
- Firm
- Novo Nordisk Inc
- FEI Number
- 2244771
- Product Code
- FMF
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- July 5, 2017
- Terminated
- April 9, 2019
- Address
- 800 Scudders Mill Rd, Plainsboro, NJ, 08536-1606
Description
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 (supplied separately). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in 0.5 increments.
A small number of batches may crack or break if exposed to certain chemicals, like certain cleaning agents.
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. **Healthcare Providers/Wholesaler/Retail Customers: Novo Nordisk requested these groups: 1) Immediately stop distribution of the affected batches and quarantine any quantities of these batches remaining in your control. 2) Conduct a physical count and record this data on the included Business Reply Card and the Packing Slip. 3) Mail the postage paid Business Reply Card even if you do not have the recalled product in your inventory. 4) Return the recalled product and the Packing Slip using the prepaid FedEx Authorized Return Service shipping label to the following address: FedEx Supply Chain 6101 North 64th Street Milwaukee, WI, 53218. Customers with any questions regarding the recall process, please call FedEx Supply Chain directly at 855-419-8827, Monday Friday 8am 6pm EST.
Nationwide distribution
16,557 units