Reported Feb 19, 2014 · Terminated
T:slim Insulin Delivery System Insulin Infusion Pump
Tandem Diabetes Care Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Tandem Diabetes Care Inc · 11045 Roselle St Ste 200 · San Diego, CA · 92121-1231
Is this the product you have?
- T:slim Insulin Delivery System Insulin Infusion Pump
- Lot codes and dates
- Lot Numbers
M000857M001414M001454M001963M002028M000869M001415M001455M001964M002029M001344M001416M001456M001973M002030M001345M001417M001457M001974M002082M001346M001420M001458M001979M002083M001347M001421M001459M001980M002096M001389M001422M001460M001987M002097M001390M001423M001528M001988M002099M001391M001451M001529M001990M002100M001392M001452M001530M001991M002119M001393M001453M001532M002027M002120
- Lot Numbers
- Amount recalled
- 12, 807 boxes (10packs)
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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