Device recall
Z-1131-2023: HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001
FDA device recall · Class II · Access Vascular, Inc
Key facts
| Recall number (Z-number) | Z-1131-2023 |
|---|---|
| Recall event | 91426 |
| Product | HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001 |
| Product code | FOZ |
| Recalling firm | Access Vascular, Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K193015 |
| FEI number | 3021570645 |
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