Device recall
Z-1338-2016: Dexcom G4 PLATINUM (Pediatric) Receiver with Share Receiver Part Number: MT22608…
FDA device recall · Class I · Dexcom Inc
Key facts
| Recall number (Z-number) | Z-1338-2016 |
|---|---|
| Recall event | 73412 |
| Product | Dexcom G4 PLATINUM (Pediatric) Receiver with Share Receiver Part Number: MT22608 Receiver (mg/dL), Black (pediatrics); MT22608-PNK, Receiver (mg/dL), Pink (pediatrics); MT22608-BLU, Receiver (mg/dL), Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with diabetes. |
| Product code | MDS |
| Recalling firm | Dexcom Inc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Aug 11, 2017 |
| PMA numbers | P120005, P120005S031 |
| FEI number | 3004753838 |
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