A followup to my post… I just got the following email from Animas!
URGENT: INSULIN PUMP 2.0 mL CARTRIDGE RECALL
February 22, 2011
Important Information about your 2.0 mL Animas Insulin Pump Cartridges
Dear Animas Pumper:
Animas Corporation is dedicated to supporting pumpers with quality customer service and products. As part of that commitment, we contact our pumpers whenever we have urgent information about our products.
We are sending you this email because we have learned that some of the 2.0 mL insulin cartridges shipped 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 an occlusion in your infusion set.
Please note that under-delivery of insulin can cause high blood sugar and/or diabetic ketoacidosis. These are serious conditions that can cause severe health impact, including death.
Our records show that you have received a shipment with cartridges that have the potential to leak. It is important that you check your cartridge supply and stop using those cartridges immediately.
Cartridge lot numbers affected by this recall are:
B201575
B201576
B201581
B201582
B201583
You can find the lot number on the side panel of the cartridge box and on the packaging of each individual cartridge next to the symbol
Lot
What if I am currently using a cartridge with one of these lot numbers in my pump? Change your cartridge immediately using the following instructions. See your Owners Booklet or User Guide for more detailed instructions.
- Disconnect the infusion set from your body.
- Unscrew the cartridge cap, leaving the tubing connected to the cartridge.
- With the tubing connected to the cartridge, pull the cartridge straight out of your pump.
- Disconnect tubing from cartridge, set the cartridge aside to return to Animas.
- Fill a new cartridge from an unaffected lot not listed above, and attach infusion set tubing.
- Rewind, load the cartridge and prime.
- Connect tubing to site once prime is complete.
What should I do if we have unused cartridges from the lots listed above? Set them aside for return to Animas. We will be sending instructions and materials to return these cartridges.
What if I don’t have any other cartridges? Go to your back up plan for insulin delivery and call your healthcare professional if you have any questions about insulin dosing. We are in the process of notifying your Health Care Providers, but you may have received notice before we reached your doctor.
How do we get replacement cartridges? We plan to be shipping replacement cartridges free of charge no later than Friday February 25. You do not need to call Animas to order these replacements.
Is there anything wrong with my pump? No, there is not a problem with the pump. Any leaking of the insulin from the cartridge will not damage your pump.
Should I adjust my basal or bolus rates to correct the under-delivery of insulin? No. If you have an affected cartridge, stop using it immediately and replace it with another cartridge that is not affected, or go to your back up plan. Also, if you have any questions about adjusting your insulin dosing, contact your health care professional.
What if I have other questions?
If you have technical questions or concerns, please call Animas Customer Support at 1-855-254-5668 or you can call the toll-free number on the back of your pump at 1-877-937-7867.
Again, Animas is dedicated to providing our pumpers with quality customer service and products. We know that you had a choice when choosing the pump that would work best for your lifestyle and we appreciate that you trusted us. We assure you that we are doing everything we can to address this issue quickly to avoid any further concerns.
Sincerely,
Animas Corporation
Note: In an attempt to make sure that we reach you, you may get more than one notice from Animas about this issue.
Animas Corporation, 200 Lawrence Dr., West Chester, PA 19380