Device recall
Z-1578-2020: 1. X-Port isp M.R.I Implantable Port, with Pre-Attached 9.6 F Open-Ended…
FDA device recall · Class II · Bard Peripheral Vascular Inc
Key facts
| Recall number (Z-number) | Z-1578-2020 |
|---|---|
| Recall event | 84914 |
| Product | 1. X-Port isp M.R.I Implantable Port, with Pre-Attached 9.6 F Open-Ended Single-Lumen Venous Catheter, REF:0607550, UDI:(01)00801741026195 2. X-Port isp M.R.I. Implantable Port, with Attachable 9.6F Open-Ended Single-Lumen Venous Catheter, REF: 0657525, UDI:(01)00801741026379 Product Usage: Bard… |
| Product code | LJT |
| Recalling firm | Bard Peripheral Vascular Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 18, 2022 |
| 510(k) numbers | K022983 |
| FEI number | 2020394 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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