Device recall
Z-1164-04: Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot…
FDA device recall · Class II · Cook, Inc.
Key facts
| Recall number (Z-number) | Z-1164-04 |
|---|---|
| Recall event | 29300 |
| Product | Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 22 mm - iliac leg diameters 11 mm - main body lengths cntralateral limb 74mm ipsilateral limb 133 mm - delivery system 18 FR; Catalog no… |
| Product code | MIH |
| Recalling firm | Cook, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 1, 2004 |
| PMA numbers | P020018 |
| FEI number | 1820334 |
At a glance
- None Linked 510(k)s
- 10–99 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