Device recall
Z-2393-2011: URI-DRAIN Standard Male External Catheter with Two-Sided Adhesive Strap and Skin…
FDA device recall · Class II · Covidien LP
Key facts
| Recall number (Z-number) | Z-2393-2011 |
|---|---|
| Recall event | 58665 |
| Product | URI-DRAIN Standard Male External Catheter with Two-Sided Adhesive Strap and Skin Protective Wipe Product ID: 8884732500 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