# FDA recall Z-1129-2023

> **Access Vascular, Inc** · Class II · device recall initiated 2022-12-16.

## 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.

## Distribution

US Nationwide distribution in the states of CT, IL, IN, MA, NE, TN, and TX.

## Key facts

- **Recall number:** Z-1129-2023
- **Recalling firm:** Access Vascular, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-12-16
- **Report date:** 2023-02-22

- **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-1129-2023

## Citation

> AI Analytics. FDA recall Z-1129-2023. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-1129-2023. Source: US FDA. Licensed CC0.

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