Device recall
Z-1084-2009: HydroSil (Intermittent Urethral Catheter), Hydrophilic 12 French Male Length…
FDA device recall · Class II · Rochester Medical Corp
Key facts
| Recall number (Z-number) | Z-1084-2009 |
|---|---|
| Recall event | 51205 |
| Product | HydroSil (Intermittent Urethral Catheter), Hydrophilic 12 French Male Length Sample Packs REF#63612SPL Rochester Medical, Distributed by Rochester Medical Ltd 10 Commerce Way, Lancing West Sussex BN158TA, Sterile R, Rochester and HydroSil are registered trademarks of Rochester Medical Corporation… |
| Product code | KOD |
| Recalling firm | Rochester Medical Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 20, 2011 |
| 510(k) numbers | K000723 |
| FEI number | 2130787 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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