Device recall
Z-0154-2023: 18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash…
FDA device recall · Class I · Insulet Corporation
Key facts
| Recall number (Z-number) | Z-0154-2023 |
|---|---|
| Recall event | 90987 |
| Product | 18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final PDM U100, mg/dL PT-000011: Assembly, Dash Final PDM U100, mmol/L PT-000030: Assembly, DASH PDM, Canada Remote Controller (Personal Diabetes Manager or PDM) associated with Insulin Pump (Pod) *The part numbers above… |
| Product code | LZG |
| Recalling firm | Insulet Corporation |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Sep 17, 2024 |
| 510(k) numbers | K211575 |
| 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