Device recall
Z-2165-2020: Omnipod DASH Insulin Management System (mmol/L configuration), Catalog Number…
FDA device recall · Class II · Insulet Corporation
Key facts
| Recall number (Z-number) | Z-2165-2020 |
|---|---|
| Recall event | 85552 |
| Product | Omnipod DASH Insulin Management System (mmol/L configuration), Catalog Number PT000011 M/D: INT1D001MM - Product Usage: is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin. |
| Product code | LZG |
| Recalling firm | Insulet Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 14, 2021 |
| 510(k) numbers | K192659 |
| FEI number | 3014585508 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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