Z-0206-2018 Class II Terminated
FDA device recall Z-0206-2018 was initiated by Novo Nordisk Inc on Jul 5, 2017 and is designated Class II. Reason for recall: A small number of batches may crack or break if exposed to certain chemicals, like certain cleaning agents. The recall status is terminated (terminated Apr 9, 2019). Affected quantity: 16,557 units.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 13, 2017
- Initiation Date
- Jul 5, 2017
- Termination Date
- Apr 9, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16,557 units
Product 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.
Reason for Recall
A small number of batches may crack or break if exposed to certain chemicals, like certain cleaning agents.
Distribution Pattern
Nationwide distribution
Code Information
U.S. batch numbers: EVG1221, EVG1226, FVG7149, FVG7458, FVG8134 & FVG8135
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0206-2018
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026