Device recall
Z-0166-2014: OmniPod Insulin Management Product Demonstration Kit; Model Reference Number…
FDA device recall · Class II · Insulet Corporation
Key facts
| Recall number (Z-number) | Z-0166-2014 |
|---|---|
| Recall event | 66425 |
| Product | OmniPod Insulin Management Product Demonstration Kit; Model Reference Number: (PDK-ZXP490) Product Usage: The Demonstration Kit (PDK-ZXP490) is an alternate kit provided to potential patients by healthcare professionals for patients to experience what wearing a Pod may feel like prior to purchase… |
| Product code | LZG |
| Recalling firm | Insulet Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 4, 2014 |
| 510(k) numbers | K122953 |
| FEI number | 3004464228 |
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