Device recall
Z-1090-2007: Medtronic Performer CPB-Universal R2100375. Catologue Number R5100052. The…
FDA device recall · Class II · Medtronic Perfusion Systems
Key facts
| Recall number (Z-number) | Z-1090-2007 |
|---|---|
| Recall event | 38154 |
| Product | Medtronic Performer CPB-Universal R2100375. Catologue Number R5100052. The Performer CPB System is an electromechanical extracorporeal support device used during cardiopulmonary bypass procedures. Manufactured by: RanD S.r.l 41036 Mendolla (MO) Italy. Distributed exclusively by Medtronic, Inc. |
| Product code | DTQ |
| Recalling firm | Medtronic Perfusion Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 2, 2008 |
| 510(k) numbers | K052555, K070213 |
| FEI number | 1000116158 |
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