FDA Device recall Z-0827-2014
T:slim Insulin Delivery System Insulin Infusion Pump
- FDA Device
- Class I
- terminated
- Published 2014-02-19
On 2014-02-19 the FDA classified a Class I recall of T:slim Insulin Delivery System Insulin Infusion Pump by Tandem Diabetes Care, citing 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 l….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0827-2014 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2014-01-10 |
| Published | 2014-02-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Tandem Diabetes Care |
| Distribution | US |
Product
T:slim Insulin Delivery System Insulin Infusion Pump
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.
Identifiers
| code_info | Lot Numbers: M000857, M001414, M001454, M001963, M002028, M000869, M001415, M001455, M001964, M002029, M001344, M001…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0827-2014%22
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