FDA Device recall Z-1156-2023
HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous access system for intraven…
- FDA Device
- Class II
- ongoing
- Published 2023-03-01
On 2023-03-01 the FDA classified a Class II recall of HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous access system for intraven… by Access Vascular, citing label with the incorrect component listed on the inner kit Tyvek header bag.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1156-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-12-22 |
| Published | 2023-03-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Access Vascular |
| Distribution | US |
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
Reason
Label with the incorrect component listed on the inner kit Tyvek header bag
Identifiers
| code_info | UDI-DI: (01)00850030354020 Lot Numbers: 11424032, 11432076 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1156-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.