Device recall
Z-0433-06: Mach 1 6F JR 3.5 Guide Catheter. Catalog No. 34356-685. Sterilized with ethylene…
FDA device recall · Class III · Boston Scientific Scimed
Key facts
| Recall number (Z-number) | Z-0433-06 |
|---|---|
| Recall event | 32922 |
| Product | Mach 1 6F JR 3.5 Guide Catheter. Catalog No. 34356-685. Sterilized with ethylene oxide gas. Nonpyrogenic. Intended for one procedure use only. Manufacture: Boston Scientific Scimed, Inc., One Scimed Place, Maple Grove, MN USA 55311 |
| Product code | DQY |
| Recalling firm | Boston Scientific Scimed |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jan 23, 2007 |
| 510(k) numbers | K010874 |
| 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