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Recall Observatory FDA recall evidence

Device product

T:slim Insulin Delivery System Insulin Infusion Pump

Z-0827-2014

January 10, 2014

Class I

Product summary

Firm
Tandem Diabetes Care Inc
Event
Event 67264
Status
Terminated
Classification
Class I
Quantity
12, 807 boxes (10packs)
Official record key
device-enforcement:Z-0827-2014

Official wording

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.

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.

Distribution pattern: USA (nationwide)

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.