Device recall
Z-0843-2021: CareLink Personal Software Therapy Management Software Tool for Diabetes…
FDA device recall · Class II · Medtronic Inc.
Key facts
| Recall number (Z-number) | Z-0843-2021 |
|---|---|
| Recall event | 86895 |
| Product | CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System Therapy Management Software Tool for Diabetes Software Uploader versions: 3.1.5.000 3.1.2.000 |
| Product code | MDS |
| Recalling firm | Medtronic Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K151236 |
| FEI number | 3003166194 |
At a glance
- 1–9 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