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Tandem Diabetes Care Inc Recall 90113

Description: t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology

Tandem Diabetes Care Inc Recall 90113 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1258-2022
Event ID90113
Event Descriptiont:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology
Product TypeDevices
DistributionInternational distribution in the country of Australia.
Quantity5,206
Recall ReasonInsulin 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.
Device Classification20220622
Device Code InfoDexcom G5 - All Serial Numbers; Basal-IQ Technology - Software Versions 6.3.01 and Earlier
Center Classification Date20220610
Recall Initiation Date20200910
Recalling FirmTandem Diabetes Care Inc
Initial Notification Letter
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