Device recall
Z-0340-2007: Medtronic Intersept Custom Tubing Pack. Do Not Reuse. The design and components…
FDA device recall · Class III · Medtronic Perfusion Systems
Key facts
| Recall number (Z-number) | Z-0340-2007 |
|---|---|
| Recall event | 36333 |
| Product | Medtronic Intersept Custom Tubing Pack. Do Not Reuse. The design and components of this product were specified by the user from an array of components and designs offered by the manufacturer. Any change in the cardiopulmonary bypass procedure that compromises the function of this Custom Tubing Pack… |
| Product code | DWE |
| Recalling firm | Medtronic Perfusion Systems |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Feb 3, 2007 |
| 510(k) numbers | K800178 |
| FEI number | 1000116158 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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