Drug recall
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology
FDA recall event 90113 · Class II · Tandem Diabetes Care Inc
Key facts
| Event ID | 90113 |
|---|---|
| Recall numbers | Z-1258-2022 |
| Recalling firm | Tandem Diabetes Care Inc |
| Product type | Devices |
| Products | t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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… |
| Initiation date | Sep 10, 2020 |
| Report date | Jun 22, 2022 |
| City | San Diego |
| State | CA |
| Country | United States |
| FEI number | 3007981285 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: