Device recall
Z-1023-2016: Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascular…
FDA device recall · Class III · Medtronic Perfusion Systems
Key facts
| Recall number (Z-number) | Z-1023-2016 |
|---|---|
| Recall event | 73261 |
| Product | Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I H/S Cuvette. The cuvette is packaged into Medtronic Perfusion Tubing Packs and only sold as part of the pack. This product is indicated for use… |
| Product code | DWF |
| Recalling firm | Medtronic Perfusion Systems |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Nov 7, 2016 |
| 510(k) numbers | K012538, K891687 |
| 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