Device recall
Z-1573-05: Enpath Steerable Sheath, model 10775-003, Sterile EO. Single Use Only. Enpath…
FDA device recall · Class II · Enpath Medical, Inc.
Key facts
| Recall number (Z-number) | Z-1573-05 |
|---|---|
| Recall event | 33338 |
| Product | Enpath Steerable Sheath, model 10775-003, Sterile EO. Single Use Only. Enpath Medical, Inc., 15301 Highway 55 West, Minneapolis, MN 55447, USA. The Enpath Deflectable Catheter is a felexible tipped percutaneous catheter designed for gaining access to the peripheral and coronary systems. The device… |
| Product code | DYB |
| Recalling firm | Enpath Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 22, 2006 |
| 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