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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1258-2022 |
| Event ID | 90113 |
| Event Description | t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology |
| Product Type | Devices |
| Distribution | International distribution in the country of Australia. |
| Quantity | 5,206 |
| Recall Reason | 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. |
| Device Classification | 20220622 |
| Device Code Info | Dexcom G5 - All Serial Numbers; Basal-IQ Technology - Software Versions 6.3.01 and Earlier |
| Center Classification Date | 20220610 |
| Recall Initiation Date | 20200910 |
| Recalling Firm | Tandem Diabetes Care Inc |
| Initial Notification | Letter |
| Similar To |