Device recall
Z-0567-04: This device is labeled as Sterile and is packaged in a Tyvek pouch with the…
FDA device recall · Class II · Cordis Corporation
Key facts
| Recall number (Z-number) | Z-0567-04 |
|---|---|
| Recall event | 27450 |
| Product | This device is labeled as Sterile and is packaged in a Tyvek pouch with the following labeling: PALMAZ Genesis TRANSHEPATIC BILIARY STENT on Aviator RX Delivery System REF Cat. No. Cordis ENDOVASCULAR Lot No. Use By Cordis Europa N.V. 9301 LJ Roden The Netherlands STERILE Min. Guiding Catheter ID… |
| Product code | MAF |
| Recalling firm | Cordis Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 5, 2009 |
| 510(k) numbers | K010411 |
| FEI number | 1016427 |
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