Device recall
Z-2394-2011: URI-DRAIN Male Urinary Control Device - Large Product ID: 8884732598 (sold in…
FDA device recall · Class II · Covidien LP
Key facts
| Recall number (Z-number) | Z-2394-2011 |
|---|---|
| Recall event | 58665 |
| Product | URI-DRAIN Male Urinary Control Device - Large Product ID: 8884732598 (sold in Canada only) Intended use:Collector urine from male patients (and accessories) for indwelling catheter |
| Product code | KNX |
| Recalling firm | Covidien LP |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 29, 2015 |
| 510(k) numbers | K770789 |
| FEI number | 1282497 |
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