FDAFDA · Food and drugs·Recall number Z-1258-2022
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology
Published June 22, 2022 · Recall initiated: September 10, 2020
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Insulin pumps may display unexpected fluctuation of the remaining battery life so ensure pump battery life does not fall below 25% remaining power. If the battery life drops to less than 5%, insulin delivery will continue for 30 minutes and then the pump will power off and insulin delivery will stop. If the battery reaches 1%, then insulin delivery will stop, which could lead to hyperglycemia.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Tandem Diabetes Care Inc
- Distributor
- International distribution in the country of Australia.
- Lot
- Dexcom G5 - All Serial Numbers; Basal-IQ Technology - Software Versions 6.3.01 and Earlier
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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