Device recall
Z-2382-2015: Celsite Implantable Access Port System, model ST301. The Celsite Implantable…
FDA device recall · Class II · B. Braun Interventional Systems
Key facts
| Recall number (Z-number) | Z-2382-2015 |
|---|---|
| Recall event | 71666 |
| Product | Celsite Implantable Access Port System, model ST301. The Celsite Implantable Access Port Systems (Celsite port systems) are implantable port and catheter systems that allow safe, repeated access to the patient's bloodstream. The port chamber and catheter design can be used for the administration of… |
| Product code | LJT |
| Recalling firm | B. Braun Interventional Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 20, 2015 |
| 510(k) numbers | K130576 |
| FEI number | 3006332832 |
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