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U.S. Department of Health and Human Services

Class 1 Device Recall T:slim Insulin Infusion Pump

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  Class 1 Device Recall T:slim Insulin Infusion Pump see related information
Date Initiated by Firm January 10, 2014
Date Posted February 10, 2014
Recall Status1 Terminated 3 on September 23, 2014
Recall Number Z-0827-2014
Recall Event ID 67264
510(K)Number K111210  
Product Classification Pump, infusion, insulin - Product Code LZG
Product T:slim Insulin Delivery System
Insulin Infusion Pump

Code Information Lot Numbers: M000857, M001414, M001454, M001963, M002028, M000869, M001415, M001455, M001964, M002029, M001344, M001416, M001456, M001973, M002030, M001345, M001417, M001457, M001974, M002082, M001346, M001420, M001458, M001979, M002083, M001347, M001421, M001459, M001980, M002096, M001389, M001422, M001460, M001987, M002097, M001390, M001423, M001528, M001988, M002099, M001391, M001451, M001529, M001990, M002100, M001392, M001452, M001530, M001991, M002119, M001393, M001453, M001532, M002027, M002120. 
Recalling Firm/
Manufacturer		 Tandem Diabetes Care Inc
11045 Roselle St Ste 200
San Diego CA 92121-1231
For Additional Information Contact
858-366-6900 Ext. 6963
Manufacturer Reason
for Recall		 Specific lots of insulin cartridges that are used with the T:slim Insulin Pump may be at risk for leaking. A cartridge leak could result in the device delivering too much or too little insulin, which can lead to a serious adverse event.
FDA Determined
Cause 2		 Equipment maintenance
Action Tandem Diabetes Care sent an Urgent Medical Device Voluntary Recall letter dated January 10, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed check the lot numbers of their cartridge supply against the llist of affected lot numbers. Do Not use any cartridges from the lots affected by this recall. If customers don't have useable cartridges, discontinue using the pump and revert to their backup plan until new supplies arrive. Customers were instructed to call Tandem Technical Support at 1-877-801-6901 to receive replacement cartridges at no charge. Customers were asked to return the enclosed return response form via email, fax, or mail. UPDATED: Tandem Diabetes Care expanded the recall om January 20, 2014. Tandem Diabetes Care¿, Inc. (NASDAQ: TNDM), 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. For questions regarding this recall calll 858-366-6900, ext 6963.
Quantity in Commerce 12, 807 boxes (10packs)
Distribution USA (nationwide)
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LZG and Original Applicant = TANDEM DIABETES CARE, INC.
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