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FDAFDA · Food and drugs·Recall number Z-0206-2018

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.

Published December 13, 2017 · Recall initiated: July 5, 2017

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

A small number of batches may crack or break if exposed to certain chemicals, like certain cleaning agents.

What to do

Voluntary: Firm initiated · Press Release

Recall details

Manufacturer
Novo Nordisk Inc
Distributor
Nationwide distribution
Lot
U.S. batch numbers: EVG1221, EVG1226, FVG7149, FVG7458, FVG8134 & FVG8135
Risk classification
Class II
Area (FDA)
device
Country
United States

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