Class 2 Device Recall NovoPen Echo

• Date Initiated by Firm: July 05, 2017
• Create Date: December 07, 2017
• Recall Status: Terminated on April 09, 2019
• Recall Number: Z-0206-2018
• Recall Event ID: 77704
• 510(K)Number: K123766 K150874 K162602
• Product Classification: Syringe, piston - Product Code FMF
• Product: 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.
• Code Information: U.S. batch numbers: EVG1221, EVG1226, FVG7149, FVG7458, FVG8134 & FVG8135
• Recalling Firm/ Manufacturer: Novo Nordisk Inc; 800 Scudders Mill Rd; Plainsboro NJ 08536-1606
• For Additional Information Contact: Anna Frable; 609-786-8126
• Manufacturer Reason for Recall: A small number of batches may crack or break if exposed to certain chemicals, like certain cleaning agents.
• FDA Determined 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. **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.
• Quantity in Commerce: 16,557 units
• Distribution: Nationwide distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FMF