Device recall
Z-0310-2011: smith&nephew EZCARE Negative Pressure Rx only. 100-240 V 12 V 50/60 Hz 90VA T1A…
FDA device recall · Class II · Smith & Nephew Inc.
Key facts
| Recall number (Z-number) | Z-0310-2011 |
|---|---|
| Recall event | 56825 |
| Product | smith&nephew EZCARE Negative Pressure Rx only. 100-240 V 12 V 50/60 Hz 90VA T1A 250 V Indicated for patients who would benefit from a suction device particularly as the device may promote healing when used with accessory wound sealing kits. Made in USA by/Fabrique aux Etals Unis par: Smith & Nephew… |
| Product code | OMP |
| Recalling firm | Smith & Nephew Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 10, 2010 |
| 510(k) numbers | K091470 |
| FEI number | 3006760724 |
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