Device recall
Z-1553-2020: Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D…
FDA device recall · Class II · Insulet Corporation
Key facts
| Recall number (Z-number) | Z-1553-2020 |
|---|---|
| Recall event | 84982 |
| Product | Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D: PDM-USA1-D001-MG-USA1 EU: PT-000010 - M/D: INT1-D001-MG PT-000011 M/D: INT1-D001-MM UDI 10385082000009 The Omnipod DASH Personal Diabetes Manager (PDM) is a mobile, handheld Android device that is intended to communicate… |
| 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