Z-0827-2014 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 19, 2014
- Initiation Date
- January 10, 2014
- Termination Date
- September 23, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12, 807 boxes (10packs)
Product Description
T:slim Insulin Delivery System Insulin Infusion Pump
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.
Distribution Pattern
USA (nationwide)
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.