Device recall
Z-1223-2018: Vital-Port Vascular Access System, Subcutaneous, implanted, intravascular…
FDA device recall · Class II · Cook Vascular Inc.
Key facts
| Recall number (Z-number) | Z-1223-2018 |
|---|---|
| Recall event | 79425 |
| Product | Vital-Port Vascular Access System, Subcutaneous, implanted, intravascular infusion port and catheter, IP, IP-S, Product usage: The devices are intended for use in patient therapy requiring long-term vascular access for infusion therapy and/or blood sampling. |
| Product code | LJT |
| Recalling firm | Cook Vascular Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 3, 2018 |
| 510(k) numbers | K081425 |
| FEI number | 2522007 |
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