DeviceClearance

Recall Z-0206-2018— Novo Nordisk Inc

Class II · Terminated

Class II FDA medical device recall by Novo Nordisk Inc, initiated 2017-07-05, terminated 2019-04-09. It names 3 FDA 510(k) clearances: K162602, K150874, K123766. 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.. Reason: A small number of batches may crack or break if exposed to certain chemicals, like certain cleaning agents..

Recalling firm
Novo Nordisk Inc
Classification
Class II
Status
Terminated
Initiated
2017-07-05
Terminated
2019-04-09
Firm location
Plainsboro, NJ, United States

510(k) clearances named in this recall

3 on FDA's record

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.