Device 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.
Z-0206-2018
Product summary
- Firm
- Novo Nordisk Inc
- Event
- Event 77704
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16,557 units
- Official record key
device-enforcement:Z-0206-2018
Official wording
Reason: A small number of batches may crack or break if exposed to certain chemicals, like certain cleaning agents.
Code information: U.S. batch numbers: EVG1221, EVG1226, FVG7149, FVG7458, FVG8134 & FVG8135
Distribution pattern: Nationwide distribution
Derived failure modes
-
Unknown
A small number of batches may crack or break if exposed to certain chemicals, like certain cleaning agents.