Device recall
Z-0257-04: Arrow Low Profile Port with Attachable Silicone Rubber Catheters/10 Fr…
FDA device recall · Class III · Arrow International Inc
Key facts
| Recall number (Z-number) | Z-0257-04 |
|---|---|
| Recall event | 27681 |
| Product | Arrow Low Profile Port with Attachable Silicone Rubber Catheters/10 Fr. Introducer Kit Implantable Vascular Access System (Product # AP-06022) [NB: plastic port] Product # AP-06022 kit contains 1 low profile implantable plastic port, 2 attachable silicone rubber catheters (8.4 Fr. x 75 cm and 9.6 Fr… |
| Product code | DYB |
| Recalling firm | Arrow International Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Nov 12, 2004 |
| 510(k) numbers | K921475, K933316, K934802 |
| FEI number | 3010532612 |
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