# FDA recall Z-1155-2023

> **Access Vascular, Inc** · Class II · device recall initiated 2022-12-22.

## 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

## Distribution

US Nationwide distribution in the states of FL, TX, WA.

## Key facts

- **Recall number:** Z-1155-2023
- **Recalling firm:** Access Vascular, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-12-22
- **Report date:** 2023-03-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Billerica, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1155-2023

## Citation

> AI Analytics. FDA recall Z-1155-2023. Retrieved 2026-07-07 from https://api.ai-analytics.org/recall/Z-1155-2023. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*