Device recall
Z-1983-2018: MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access…
FDA device recall · Class II · Arrow International Inc
Key facts
| Recall number (Z-number) | Z-1983-2018 |
|---|---|
| Recall event | 79890 |
| Product | MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve and Sharps Safety Features for use with 7.5 - 8 Fr. Catheters; Product Code: ASK-21242-NYP and ASK-21242-PR |
| Product code | FOZ |
| Recalling firm | Arrow International Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 15, 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