Device recall
Z-0165-2014: OmniPod Insulin Management System Starter Kit; Model Reference Number…
FDA device recall · Class II · Insulet Corporation
Key facts
| Recall number (Z-number) | Z-0165-2014 |
|---|---|
| Recall event | 66425 |
| Product | OmniPod Insulin Management System Starter Kit; Model Reference Number: SKT-UST400 (Starter Kit) Product Usage: The Starter Kit (SKT-UST400) is provided to users as an introduction to the OmniPod Insulin Management System prior to initiating care. It includes the Personal Diabetes Manager (PDM) with… |
| 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