Novopen Echo Insulin Device Recall [US]


US FlagUS/Silver Spring: Novopen Echo Insulin Device Recall [US]Novo Nordisk recalls certain batch/lots of Cartridge Holders for Novopen Echo Insulin Delivery Devices due to suspected risk of creaking and/or breakage and consequential Insulin delivery failure, Hyperglycemia and resultant life-threatening complications, all serious health hazards. FDA: http://ht.ly/Aquy30ds3rj

Direct link: https://www.fda.gov/Safety/Recalls/ucm565936.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the following medical devices are subject to this recall:

  • Cartridge Holders for Novopen Echo Insulin Delivery Devices, batch/lots: EVG1221, EVG1226, FVG7149, FVG7458, FVG8134, FVG8135. The affected batches are known to have been distributed between 8/1/2016 and 6/22/2017 to distributors, sales representatives and replacement programs for further distribution to pharmacies, healthcare providers and patients US nationwide.

==> No barcodes, UPCs, item numbers, DINs or other identification numbers were listed with this recall notification.

According to the FDA, Novo Nordisk certain batch/lots of Cartridge Holders for Novopen Echo Insulin Delivery Devices due to suspected risk of creaking and/or breakage due to exposure to certain chemicals, such as certain cleaning agents.

NovoPen Echo is used for Insulin treatment by people with Diabetes. Using a device with a cracked/broken cartridge holder may result in the device delivering a reduced dose of Insulin which, in turn, could potentially lead to high blood sugar (“Hyperglycemia”). Novo Nordisk has received numerous complaints of damaged Cartridge Holders and has received some reports of adverse events to date.

The warning signs of Hyperglycemia include flushed, dry skin; feeling sleepy or tired; dry mouth, “fruity” breath (acetone); urinating more often, feeling thirsty; loss of appetite, nausea and/or vomiting. Patients using an affected pen should check their blood sugar levels more frequently than normal until receiving a new Cartridge holder.

==> If you think you or someone in your care is experiencing Hyperglycemia, you should contact your health care provider on an emergency basis. If immediate care cannot be found, please visit the emergency department of your local hospital.

If you believe you have purchased or have in your possession any of the recalled Cartridge Holders for Novopen Echo Insulin Delivery Devices, continue using them until you receive replacements Cartridges but take additional precautions as specified above including monitoring and treating your blood sugar levels as necessary.

If you have any questions about this recall, please contact Novo Nordisk at 1-855-419-8827.

___________________________________________________________

More information about this recall:
Recalls Direct RIN: 8917-2017
Want to read more about this recall?
==> Please click on the links above to visit the originating site.
Want to read more about other recalls?
==> Please click on the links below.

General information:
More recalls? Back to the main Recalls Direct page:
==> http://www.RecallsDirect.com/
About the Recalls Direct service:
==> http://wp.me/P2bVty-2
Visit the Living Safely site:
==> http://www.LivingSafely.org/
Report an unsafe food or drug you purchased in the US [external: new window opens]:
==> http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm095859.htm
Search for a recalled food or drug on the US FDA Web archive [external: new window opens]:
==> http://www.fda.gov/Safety/Recalls/ArchiveRecalls/default.htm

 

We welcome your feedback:
Want to e-mail or share this recall?
==> Simply use the “Share this” options below.
Is this recall relevant to you? Please let us know!
==> Click on the “Like” button below.
E. & O. E.

___________________________________________________________

Advertisements
%d bloggers like this: