Drug recall
t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ…
FDA recall event 90628 · Class II · Tandem Diabetes Care Inc
Key facts
| Event ID | 90628 |
|---|---|
| Recall numbers | Z-1811-2022, Z-1812-2022 |
| Recalling firm | Tandem Diabetes Care Inc |
| Product type | Devices |
| Products | t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim x2 insulin pump with the Control-IQ Technology |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Insulin pumps may have the following issues: 1) Malfunction 6 Non-Volatile Memory, 2) Inaccurate (Fluctuating) Battery Life Display, 3) Touchscreen Staying On, 4) Unexpected Open Loop, that can be… |
| Initiation date | May 24, 2022 |
| Report date | Oct 5, 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: