Tandem Diabetes Care Recalls Some t:slim Insulin Pump Cartridges

This press release is an announcement submitted by Tandem Diabetes Care, Inc., and was not written by Diabetes Health.

Jan 11, 2014

San Diego-based Tandem Diabetes Care®, Inc. announced Friday that it is voluntarily recalling specific lots of insulin cartridges that are used with the t:slim® Insulin Pump. The affected cartridges may be at risk for leaking.

Tandem will provide replacement cartridges to its customers at no charge.

The company identified the potential problem during internal product testing. Although Tandem has not received any complaints or reports of adverse events from customers, it has determined that a cartridge leak could potentially result in the device delivering too much or too little insulin, which could 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 December 17, 2013. The affected lots represent approximately 4,746 boxes of cartridges (10 cartridges per box).

Affected Lot Numbers:

M001963   M001964   M001973

M001974   M001979   M001980

M001987   M001988   M001990

M001991   M002027   M002028

M002029   M002030   M002082

M002083   M002096   M002097

M002099   M002100   M002119

M002120

All 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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Categories: Insulin Cartridges, Recall, t:slim Insulin Pump, Tandem Diabetes Care


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