Device recall
Z-0104-2008: Boston Scientific mach 1 Guide Catheter, VL3.5 SH Voda Left 3.5, REF 34358-78…
FDA device recall · Class II · Boston Scientific
Key facts
| Recall number (Z-number) | Z-0104-2008 |
|---|---|
| Recall event | 44901 |
| Product | Boston Scientific mach 1 Guide Catheter, VL3.5 SH Voda Left 3.5, REF 34358-78, UPN H74934358780, Sterile EO, Made in Mexico Avenida Norske Edicficio G1, Local B y H Parque Industrial La Mesa, Fracc. Rubio La Mesa, Tijuana, B.C. Mexico C.P. 22550 |
| Product code | DQY |
| Recalling firm | Boston Scientific |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 24, 2008 |
| 510(k) numbers | K020028 |
| FEI number | 3002095335 |
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