Device recall
Z-1443-05: Oscor Introducer Kits Model LLP series. Luer-Lock Peel-Away Introducer Set. Each…
FDA device recall · Class II · Guidant Corporation
Key facts
| Recall number (Z-number) | Z-1443-05 |
|---|---|
| Recall event | 32395 |
| Product | Oscor Introducer Kits Model LLP series. Luer-Lock Peel-Away Introducer Set. Each set contains: 1 peel-away sheath with built-in luer-lock; 1 vessel dilator; 1 50-cm guidewire 1 18-G needle; 1 10-cc syringe. Sterile EO. Manufacturer Oscor Inc. 3816 DeSoto Boulevard, Palm Harbor, FL 34683. Guidant… |
| Product code | DYB |
| Recalling firm | Guidant Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 5, 2007 |
| 510(k) numbers | K831751 |
| FEI number | 2124215 |
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