Device recall
Z-0909-04: This medical device is packaged in an inner Tyvek pouch and then in an outer…
FDA device recall · Class I · Cordis Corporation
Key facts
| Recall number (Z-number) | Z-0909-04 |
|---|---|
| Recall event | 28840 |
| Product | This medical device is packaged in an inner Tyvek pouch and then in an outer carton. The outer carton is labeled as Cordis PRECISE RX Nitinol Stent Transhepatic Biliary System Cordis a Johnson n Johnson Company ENDOVASCULAR Cat. No. Lot No. Use By. The inner pouch is similarly labled. |
| Product code | FGE |
| Recalling firm | Cordis Corporation |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Aug 30, 2010 |
| 510(k) numbers | K032137 |
| 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