Device recall
Z-1156-2023: HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access…
FDA device recall · Class II · Access Vascular, Inc
Key facts
| Recall number (Z-number) | Z-1156-2023 |
|---|---|
| Recall event | 91533 |
| Product | HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Number: 80004004 |
| Product code | FOZ |
| Recalling firm | Access Vascular, Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K203069 |
| 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