Device recall
Z-1425-04: Telesheath Left Atrial Introducer System Right Superior. Telesheath Catheter…
FDA device recall · Class II · St. Jude Medical/Daig Division
Key facts
| Recall number (Z-number) | Z-1425-04 |
|---|---|
| Recall event | 29848 |
| Product | Telesheath Left Atrial Introducer System Right Superior. Telesheath Catheter Two-Piece Introducer Kit with Hemostasis Valve. Right Superior Reorder #407900. The product is packaged in an open, semi-rigid plastic tray, which is then placed in a sterile barrier pouch consisting of Tyvek on one side… |
| Product code | DYB |
| Recalling firm | St. Jude Medical/Daig Division |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 21, 2005 |
| 510(k) numbers | K964518, K973840, K982187 |
| FEI number | 2182269 |
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