PlainRecalls
FDA Devices Moderate Class II Terminated

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 i

Reported: December 13, 2017 Initiated: July 5, 2017 #Z-0206-2018

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.

Details

Recalling Firm
Novo Nordisk Inc
Units Affected
16,557 units
Distribution
Nationwide distribution
Location
Plainsboro, NJ

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Novo Nordisk Inc. Units affected: 16,557 units.
Why was this product recalled? ▼
A small number of batches may crack or break if exposed to certain chemicals, like certain cleaning agents.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 13, 2017. Severity: Moderate. Recall number: Z-0206-2018.

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