Device recall
Z-0538-2007: Biosense Webster PREFACE Guiding Sheath, Multipurpose 62cm, for the introduction…
FDA device recall · Class II · Biosense Webster, Inc.
Key facts
| Recall number (Z-number) | Z-0538-2007 |
|---|---|
| Recall event | 36988 |
| Product | Biosense Webster PREFACE Guiding Sheath, Multipurpose 62cm, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog Number 301803M |
| Product code | DYB |
| Recalling firm | Biosense Webster, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 25, 2009 |
| 510(k) numbers | K001139 |
| FEI number | 3003113629 |
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