Device recall
Z-2588-2014: GALT VALVED TEARAWAY INTRODUCER SET GALT VTI RX ONLY UNITS 7 STERILE EO Product…
FDA device recall · Class II · Galt Medical Corporation
Key facts
| Recall number (Z-number) | Z-2588-2014 |
|---|---|
| Recall event | 68939 |
| Product | GALT VALVED TEARAWAY INTRODUCER SET GALT VTI RX ONLY UNITS 7 STERILE EO Product Usage: Used in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature. |
| Product code | DYB |
| Recalling firm | Galt Medical Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 26, 2016 |
| 510(k) numbers | K112398 |
| FEI number | 3000718472 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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