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
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.