Device recall
Z-2383-2011: Gyrus ACMI, REF 25 BX, PTFE Coated 3 cm Flexible Tip Guidewire,.035" x 150 cm…
FDA device recall · Class II · Gyrus Acmi, Incorporated
Key facts
| Recall number (Z-number) | Z-2383-2011 |
|---|---|
| Recall event | 58650 |
| Product | Gyrus ACMI, REF 25 BX, PTFE Coated 3 cm Flexible Tip Guidewire, .035" x 150 cm, Sterile EO, Rx Only, Gyrus ACMI, Inc. 136 Turnpike Road,Southborough, MA 01772-2104 USA Ureteral guidewires are used to establish access in the urinary system for the passage of urological devices. An introducer is first… |
| Product code | KNY |
| Recalling firm | Gyrus Acmi, Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 23, 2012 |
| FEI number | 3003790304 |
At a glance
- None 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