Device recall
Z-2226-2008: Gyrus ACMI 10 Fr. Dual Lumen Catheter Reference Number: 608 BX (Box of 5) and…
FDA device recall · Class II · Gyrus ACMI Corporation
Key facts
| Recall number (Z-number) | Z-2226-2008 |
|---|---|
| Recall event | 48691 |
| Product | Gyrus ACMI 10 Fr. Dual Lumen Catheter Reference Number: 608 BX (Box of 5) and 608 (single unit) This product has multiple uses, including ureteral dilation, anesthetic injection, stone displacement, contrast injection, and safety wire / guidewire placement. The "ACMI" Dual Lumen Catheter is a… |
| Product code | EYB |
| Recalling firm | Gyrus ACMI Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 7, 2012 |
| 510(k) numbers | K043581 |
| FEI number | 3003790304 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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