Device recall
Z-1584-05: Cook brand Fascial Dilator; 10FR/37cm, sterile, Rx Only, Cook Ireland Ltd…
FDA device recall · Class II · Cook Urological, Inc.
Key facts
| Recall number (Z-number) | Z-1584-05 |
|---|---|
| Recall event | 32912 |
| Product | Cook brand Fascial Dilator; 10FR/37cm, sterile, Rx Only, Cook Ireland Ltd., Limerick, Ireland; REF G14191; Catalog No. 073710. |
| Product code | KOE |
| Recalling firm | Cook Urological, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 26, 2005 |
| 510(k) numbers | K811833 |
| FEI number | 1825146 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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