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Tandem Diabetes Care Initiates Voluntary Recall for Specific Lots of Insulin Cartridges Used with t:slim Insulin Pump
Date:1/10/2014

SAN DIEGO, Jan. 10, 2014 /PRNewswire/ -- Tandem Diabetes Care®, Inc. (NASDAQ: TNDM) today announced 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.  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.

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"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 NumbersM001963

M001980

M002027

M002083

M002119M001964

M001987

M002028

M002096

M002120M001973

M001988

M002029

M002097M001974

M001990

M002030

M002099M001979

M001991

M002082

M002100All other cartridge lots and the t:slim Insulin Pump are not affected b
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SOURCE Tandem Diabetes Care, Inc.
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