Device recall
Z-0566-04: The device is in a tyvek pouch and is labeled in part: Aviator Peripheral…
FDA device recall · Class II · Cordis Corporation
Key facts
| Recall number (Z-number) | Z-0566-04 |
|---|---|
| Recall event | 27450 |
| Product | The device is in a tyvek pouch and is labeled in part: Aviator Peripheral Dilatation Catheter REF Cat. No. Lot No., Use By Manufactured for: Cordis Europa N.V. 9301 LJRoden The Netherlands Method of Sterilization ETO Min. Guiding Catheter ID Nominal Pressure Rated Burst Pressure |
| Product code | MAF |
| Recalling firm | Cordis Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 5, 2009 |
| 510(k) numbers | K013851 |
| 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