FDA-Device2014-02-19Class I

T:slim Insulin Delivery System Insulin Infusion Pump

Tandem Diabetes Care Inc
Hazard

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.

Sold states
USA (nationwide)
Affected count
12, 807 boxes (10packs)
Manufactured in
11045 Roselle St Ste 200, N/A, San Diego, CA, United States
Products
T:slim Insulin Delivery System Insulin Infusion Pump

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0827-2014

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