Device recall
Z-0808-05: Medtronic Custom Packs and Total System Packs. Pack can contain a number of…
FDA device recall · Class II · Medtronic Perfusion Systems
Key facts
| Recall number (Z-number) | Z-0808-05 |
|---|---|
| Recall event | 31477 |
| Product | Medtronic Custom Packs and Total System Packs. Pack can contain a number of different components specified by the customer and individualized for their bypass circuit set up requirements. Intersept Custom Tubing Pack, Sterile and nonpyrogenic Fluid Path: Do not use if package is opened or damaged… |
| Product code | DWE |
| Recalling firm | Medtronic Perfusion Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 17, 2005 |
| 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