Device recall
Z-2471-2018: t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4.3…
FDA device recall · Class II · Tandem Diabetes Care Inc
Key facts
| Recall number (Z-number) | Z-2471-2018 |
|---|---|
| Recall event | 79887 |
| Product | t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4.3, Firmware version: 004722, Firmware, Fuel Gauge, Binary Rev B. |
| Product code | OYC |
| Recalling firm | Tandem Diabetes Care Inc |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P140015 |
| FEI number | 3007981285 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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