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Tuesday, January 21, 2014

TANDEM DIABETES: URGENT MEDICAL DEVICE VOLUNTARY RECALL UPDATE: ADDITIONAL LOT NUMBERS

I just got this in my email minutes ago:

URGENT MEDICAL DEVICE VOLUNTARY RECALL
UPDATE:  ADDITIONAL LOT NUMBERS
Select Lots of Insulin Cartridges Used with the t:slim® Insulin Pump

January 20, 2014
Dear Valued Customer,
On January 10, 2014, Tandem Diabetes Care began notifying customers of a Voluntary Medical Device Recall for specific lots of insulin cartridges used with the t:slim® Insulin Pump, noting that the affected cartridges may be at risk for leaking. Through further investigation, we have identified additional lot numbers of insulin cartridges that could be affected.  As a result, we are now recalling additional lots of insulin cartridges as noted in the list below.

A cartridge leak could potentially result in the delivery of too much or too little insulin, which could lead to unexpected high or low blood glucose levels.  Too much insulin can result in severe low blood sugar (hypoglycemia), and too little insulin can lead to severe high blood sugar (hyperglycemia), both of which can lead to serious injury or death.
We have identified the cause of the potential cartridge leak and have modified our cartridge manufacturing testing process to prevent this issue from occurring in the future.

What should you do?
1.  Check the lot numbers of your cartridge supply against the updated list of affected lot numbers found below.
2.  Do NOT use any cartridges from the lots affected by this recall.  If you don’t have useable cartridges, discontinue using the pump and revert to your backup plan until new supplies arrive.
3.  If you have unused affected product on hand, call Tandem Technical Support at 1-877-801-6901 to receive replacement cartridges at no charge.  Our team is available 24/7.

We are sending this message to all Tandem customers so that you are aware of the recall.  If you are directly affected by this recall you will receive a letter in the mail from Tandem Diabetes Care or the distributor from whom you purchase your pump supplies. 
Click here for more information and a list of frequently asked questions (FAQ) about this recall.  If you have any questions about the recall, please don’t hesitate to reach out to Customer Technical Support.  Our Technical Support Team is available 24/7 at (877) 801-6901.
We sincerely apologize for the inconvenience.  Your safety is our top priority, and we are committed to quickly addressing issues when they arise.  Our goal is to always provide you with quality products and superior customer service.
Thank you for being a part of the Tandem family.
Sincerely,

Kim Blickenstaff
President & CEO




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