HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short… — Class II medical device recall Z-1155-2023
Ongoing recall by Access Vascular, Inc, reported 2023-03-01, distributed nationwide. Product Mislabeled on the outer bag and inner kit Tyvek header bag
| Recall number | Z-1155-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Access Vascular, Inc, Billerica, MA, United States |
| Recall initiated | 2022-12-22 |
| Classified | 2023-02-22 |
| Reported by FDA | 2023-03-01 |
| Distributed | Nationwide (US) |
| Quantity | 155 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00850030354020 |
| Lot numbers | 11434018 |
| Model numbers | 80004004 |
Product
HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Model Number: 80004004
Reason for recall
Product Mislabeled on the outer bag and inner kit Tyvek header bag
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1155-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.