Device recall
Z-0394-2016: OmniPod, Insulin Management System (OUS) Catalog Number: 14810 Product Usage…
FDA device recall · Class I · Insulet Corporation
Key facts
| Recall number (Z-number) | Z-0394-2016 |
|---|---|
| Recall event | 72535 |
| Product | OmniPod, Insulin Management System (OUS) Catalog Number: 14810 Product Usage: The OmnniPod Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of… |
| Product code | LZG |
| Recalling firm | Insulet Corporation |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Mar 7, 2017 |
| 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