Device recall
Z-0769-2012: SYNERGY Perfusion Tubing Systems US Denver PHISIO, Sorin Group USA, Tubing set…
FDA device recall · Class II · Sorin Group USA, Inc.
Key facts
| Recall number (Z-number) | Z-0769-2012 |
|---|---|
| Recall event | 60737 |
| Product | SYNERGY Perfusion Tubing Systems US Denver PHISIO, Sorin Group USA, Tubing set heart-lung bypass, Sterile EO, manufactured by: Sorin Group Italia, Via Statale 12 Nord, 86, 41037 Mirandola (MO) Italy. Intended for use in small-adult or adult surgical procedures requiring extracorporeal gas exchange… |
| Product code | KFM |
| Recalling firm | Sorin Group USA, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 13, 2012 |
| 510(k) numbers | K032040 |
| FEI number | 1718850 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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