HydroMID 4Fr Single Lumen — Class II medical device recall Z-1129-2023
Ongoing recall by Access Vascular, Inc, reported 2023-02-22, distributed nationwide. Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire
| Recall number | Z-1129-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Access Vascular, Inc, Billerica, MA, United States |
| Recall initiated | 2022-12-16 |
| Classified | 2023-02-10 |
| Reported by FDA | 2023-02-22 |
| Distributed | Nationwide (US) |
| Quantity | 1,789 hydromid |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00850030354006 |
| Lot numbers | 11393260, 11395226, 11428361 |
| Model numbers | 80004002 |
Product
HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002
Reason for recall
Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.
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-1129-2023. 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.