Tandem Diabetes Care Inc. announced Jan. 10 that it is initiating a voluntary recall of 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, the company said in a news release. 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 safety of our customers is our top priority, and we are committed to quickly addressing issues if they arise," said Kim Blickenstaff, president and CEO of Tandem Diabetes Care. "The potential for a cartridge leak was identified during in-house product testing, and the cause has been identified. Modifications to our cartridge manufacturing process have been implemented to prevent this issue from occurring in the future."
Customers should discontinue using cartridges labeled with the below lot numbers, which were shipped on or after Dec. 17, 2013. The affected lots represent approximately 4,746 boxes of cartridges (10 cartridges per box).