Recall: Tandem Diabetes Care Insulin Cartridges for t:slim Insulin Pump

Tandem Diabetes Care®, Inc.  or Tandem, today announced that it is expanding 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. This could potentially result in the device delivering too much or too little insulin, which can lead to a serious adverse event.

Company Is Providing Replacement Cartridges to Its Customers at No Additional Charge
Consumer Contact: 1-877-801-6901

“The safety of our customers is our top priority. For that reason, even after our previous announcement Tandem’s team continued to perform further testing. Based on this work we recognized that additional cartridge lots could also be at risk for leaking and so we are expanding the scope of this recall,” said Kim Blickenstaff, President and CEO of Tandem. “We are confident that we have identified all of the affected cartridge lots that may have been shipped to customers or distributors and that we have implemented appropriate corrective actions to prevent this from happening in the future.”

Customers should discontinue using cartridges labeled with any of the lot numbers listed below. The affected lots shipped to customers or distributors represent an aggregate of approximately 13,000 boxes of cartridges (10 cartridges per box). The affected lots announced on January 10, 2014 were shipped from December 17, 2013 to January 10, 2014. The affected lots announced on January 20, 2014 were shipped prior to October 16, 2013.

Affected Lot Numbers
Announced January 20, 2014Announced January 10, 2014
M000857M001414M001454M001963M002028
M000869M001415M001455M001964M002029
M001344M001416M001456M001973M002030
M001345M001417M001457M001974M002082
M001346M001420M001458M001979M002083
M001347M001421M001459M001980M002096
M001389M001422M001460M001987M002097
M001390M001423M001528M001988M002099
M001391M001451M001529M001990M002100
M001392M001452M001530M001991M002119
M001393M001453M001532M002027M002120

All other cartridge lots shipped to customers or distributors and the t:slim Insulin Pump are not affected by this recall. The Company, or its authorized distributors, is asking customers who received affected cartridges 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.

 

The Company has determined that under certain conditions a specific piece of equipment used in the cartridge test process caused the affected cartridges to be at risk for leaking. Tandem has already implemented modifications to the cartridge manufacturing test process to prevent this issue from occurring in the future, and the Company’s manufacturing facility is able to support ongoing customer demand.

The Company is working with its customers and distributors to replace cartridges subject to the recall. Based on the periods during which the affected lots were shipped, the Company believes a significant number of the affected cartridges have already been used and therefore will not be exchanged. In addition to the expenses associated with replacing affected cartridges, the Company may also incur additional logistical shipping fees and other recall coordination costs. Tandem is also in the process of evaluating additional cartridges still in the Company’s internal inventory to determine whether they will be usable, and may incur expenses with those that are unusable.

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