Device recall
Z-1000-2018: ARROWg+ard Blue MAC" Two-Lumen Central Venous Access Kit Product Usage: The…
FDA device recall · Class II · Arrow International Inc
Key facts
| Recall number (Z-number) | Z-1000-2018 |
|---|---|
| Recall event | 79339 |
| Product | ARROWg+ard Blue MAC" Two-Lumen Central Venous Access Kit Product Usage: The Arrow CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications… |
| Product code | FOZ |
| Recalling firm | Arrow International Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 22, 2020 |
| 510(k) numbers | K011761 |
| FEI number | 3015859709 |
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