Device recall
Z-0910-2013: Leonard 10.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with…
FDA device recall · Class II · Bard Access Systems
Key facts
| Recall number (Z-number) | Z-0910-2013 |
|---|---|
| Recall event | 64425 |
| Product | Leonard 10.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system (product code 0600630). Product Usage: Hickman and Leonard Catheters are designed for long-term vascular access and for use in patients that lack adequate peripheral venous… |
| Product code | DYB |
| Recalling firm | Bard Access Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 3, 2014 |
| 510(k) numbers | K830233 |
| FEI number | 3006260740 |
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