Class II — Access Vascular, Inc
| Recalling firm | Access Vascular, Inc |
|---|---|
| Registered facility | ACCESS VASCULAR, INC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Label with the incorrect component listed on the inner kit Tyvek header bag |
| 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 |
| Quantity | 445 units |
| Distribution | US Nationwide distribution in the states of CT, FL, NE, TN, TX, WA. |
| Initiated | 2022-12-22 |
| Classified | 2023-02-22 |
| Recall number | Z-1156-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Access Vascular, Inc (Z-1156-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91533/
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