Device recall
Z-1258-2022: t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump…
FDA device recall · Class II · Tandem Diabetes Care Inc
Key facts
| Recall number (Z-number) | Z-1258-2022 |
|---|---|
| Recall event | 90113 |
| Product | t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology |
| Product code | PQF |
| Recalling firm | Tandem Diabetes Care Inc |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3007981285 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database