Device recall
Z-2451-2008: DYONICS 25 Fluid Management System Bag for enclosure of wireless remote control…
FDA device recall · Class II · Smith & Nephew, Inc. Endoscopy Division
Key facts
| Recall number (Z-number) | Z-2451-2008 |
|---|---|
| Recall event | 49132 |
| Product | DYONICS 25 Fluid Management System Bag for enclosure of wireless remote control included with Disposable Patient Tubeset. Catalog # 7211008. Bag is used for remote control in a sterile field. |
| Product code | HRX |
| Recalling firm | Smith & Nephew, Inc. Endoscopy Division |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 8, 2012 |
| 510(k) numbers | K051326 |
| FEI number | 3003604053 |
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