Device recall
Z-0323-03: Product is packaged and labeled as: ''Cordis PRECISE Nitinol Stent Transhepatic…
FDA device recall · Class II · Cordis Corporation
Key facts
| Recall number (Z-number) | Z-0323-03 |
|---|---|
| Recall event | 25043 |
| Product | Product is packaged and labeled as: ''Cordis PRECISE Nitinol Stent Transhepatic Billiary System'', Catalog Nos. N820SB, N830SB, N840SB, N920SB, N930SB, N940SB, N1020SB, N1030SB, N1040SB only. This recall also affects Cordis PRECISE Nitinol Stent System, not distributed in the United States, Catalog… |
| Product code | FGE |
| Recalling firm | Cordis Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 25, 2008 |
| 510(k) numbers | K012993 |
| FEI number | 1016427 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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