Device recall
Z-2385-2018: Peripherally Inserted Midline Catheter Kit with Placement Wire, REF MK-02031-TW…
FDA device recall · Class II · Arrow International Inc
Key facts
| Recall number (Z-number) | Z-2385-2018 |
|---|---|
| Recall event | 80299 |
| Product | Peripherally Inserted Midline Catheter Kit with Placement Wire, REF MK-02031-TW Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava… |
| Product code | LJS |
| Recalling firm | Arrow International Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 2, 2020 |
| 510(k) numbers | K963257 |
| FEI number | 3015859709 |
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