Device recall
Z-1203-2021: Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalog…
FDA device recall · Class II · Insulet Corporation
Key facts
| Recall number (Z-number) | Z-1203-2021 |
|---|---|
| Recall event | 87305 |
| Product | Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalog Number: PT 000002 XXX XXX XX PT 000318 PT 000319 Distributed to: Canada (French only), the Netherlands, France, Austria, Germany, Belgium, Greece, Turkey, Norway, Sweden, Denmark, and Finland |
| Product code | LZG |
| Recalling firm | Insulet Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 8, 2023 |
| 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