Tandem Diabetes Care®, Inc. has recalled specific lots of insulin cartridges that are used with the t:slim® Insulin Pump. The affected cartridges may be at risk for leaking. The cause of the recall was identified during Tandem’s internal product testing, and has not been associated with any complaints or adverse events reported by customers. However, a cartridge leak could potentially result in the device delivering too much or too little insulin, which can lead to a serious adverse event.
The potential for a cartridge leak was identified during in-house product testing, and the cause has been identified. Customers should discontinue using cartridges labeled with the below lot numbers, which were shipped on or after December 17, 2013. The affected lots represent approximately 4,746 boxes of cartridges (10 cartridges per box).
According to the company, no other cartridge lots and the t:slim Insulin Pump are not affected by this recall. Customers who received affected cartridges are being contacted by the Company or its authorized distributors and asked to call Tandem Technical Support to receive replacement cartridges at no charge. Tandem expects to have sufficient quantities of cartridges to replace affected lots in a timely manner. Tandem Customer Support is available 24 hours a day, 7 days a week at 1-877-801-6901.
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