Recall Z-0827-2014 ยท LZG Pump, Infusion, Insulin
Tandem Diabetes Care Inc
T:slim Insulin Delivery System Insulin Infusion Pump
| Date | Feb 10, 2014 (initiated Jan 10, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 1-87 |
| Quantity | 12, 807 boxes (10packs) |
| Distribution | USA (nationwide) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111210 | T:SLIM (TM) INSULIN DELIVERY SYSTEM Tandem Diabetes Care, Inc., Nov 9, 2011 |