Device recall
Z-0814-2014: MRI Low Profile Single Lumen port with Open-Ended 6.6Fr Silicone Catheter…
FDA device recall · Class II · Bard Access Systems
Key facts
| Recall number (Z-number) | Z-0814-2014 |
|---|---|
| Recall event | 66991 |
| Product | MRI Low Profile Single Lumen port with Open-Ended 6.6Fr Silicone Catheter. Product Code 0603880. Product Usage: The 6.6 Fr Open-Ended Single-Lumen venous catheters is packaged into various Bard Acess Systems finished goods as Attachable or Preconnected catheters in BardPort Implanted Port Kits These… |
| Product code | FOZ |
| Recalling firm | Bard Access Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 5, 2014 |
| FEI number | 3006260740 |
At a glance
- None 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