Safety Alerts & Recalls

What does this mean?

Since the recalled product can cause under-delivery of insulin and lead to serious complications from high blood sugar and/or diabetic ketoacidosis, this recall alert should be taken seriously. Symptoms of diabetic ketoacidosis may include nausea, vomiting, shortness of breath and excess thirst or urination. Contact your healthcare professional immediately if you are experiencing any of these symptoms.

If you use an Animas Insulin Pump, it is important that you check your cartridge supply for these recalled lots. You can find the lot number on the side panel of the cartridge box and on the packaging of each individual cartridge. If you are currently using a cartridge with one of these recalled lot numbers in your pump, you should change your cartridge immediately. Instructions for changing your cartridge can be found in the Owners Booklet or User Guide, and on the website for the recall alert under the section of Frequently Asked Questions: https://www.animas.com/urgent-new

If you do not have any additional cartridges on hand and need to replace your insulin cartridge, please go to your backup insulin administration plan or contact your healthcare professional for additional guidance about insulin dosing.

If you are a pump user who was affected by the recall, you should have received a supply of new 2.0 mL insulin cartridges to replace your existing supply by March 2, 2011. All replacement cartridges should have been sent to you free of charge. The replacements are clearly affixed with a green dot for ease of identification and to ensure they are not confused with the affected cartridges that must be returned. If you have any affected supply, you will be also be provided with instructions about how to return your affected cartridges.

If you have questions about this recall, please contact Animas Customer Support at 1-855-254-5668 or 1-877-937-7867. If you have medical concerns about your insulin pump therapy, please follow up with your healthcare professional.

Animas Insulin Pump 2.0 mL Cartridge Recalled

Animas Corporation has sent a letter to its customers to notify them that some of the 2.0 mL insulin cartridges shipped from Animas between Nov. 30, 2010 and Jan. 4, 2011, can leak insulin, resulting in the delivery of less insulin than intended. In addition, if the cartridge has a leak, the pump may not alarm if there is a blockage in the infusion set. The under-delivery of insulin can cause lead to serious complications from high blood sugar and/or diabetic ketoacidosis.

The Animas Insulin Pump 2.0 mL Cartridge lot numbers affected by this recall are: B201575

B201576

B201581

B201582

B201583

It is important to note that, this is a contained incident and this issue relates solely to the cartridges contained in the lots listed above. Once the cartridges are replaced, the pump will function as intended. There is not a problem with the pump.

Insulin is available in a many different formulations, brands, and packaging. This recall only applies to the 5 specific lot numbers of Animas Insulin Pump 2.0 mL Cartridges listed above.

For more information and a list of Frequently Asked Questions about this recall, please visit: more information here

Source: Manufacturer
Publication Date: 2011-03-08
Last Updated: 2011-03-08

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