Device recall
Z-0118-2007: Channel Steerable Sheath in 8F Enpath part # 10775-003, BARD Part Number…
FDA device recall · Class II · Enpath Medical, Inc.
Key facts
| Recall number (Z-number) | Z-0118-2007 |
|---|---|
| Recall event | 35827 |
| Product | Channel Steerable Sheath in 8F Enpath part # 10775-003, BARD Part Number XD10775003 (US Distribution Only) and 9F Enpath part # 10775-004 (foreign distribution), BARD Part Number XD10775004; Labeled as Distributed by Bard Electrophysiology Division. |
| Product code | DQY |
| Recalling firm | Enpath Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 14, 2007 |
| 510(k) numbers | K043489 |
| FEI number | 2183787 |
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