# FDA recall Z-0102-2023

> **ARROW INTERNATIONAL Inc.** · Class II · device recall initiated 2022-09-14.

## Product

ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHVA1.  For peripheral access to the venous system for intravenous therapy, blood sampling, infusion, and pressure injection of contrast media.

## Reason for recall

Mislabeling:  the corrugate label,  lidstock, banner card, and peel sticker accompanying the affected product incorrectly displays a double lumen 5.5 French catheter (and related priming volumes and kit contents for product code ASK-41552-JHVA1), instead of the packaged single-lumen 4.5 French catheter (and related priming volumes and kit contents for product code ASK-41541-JHVA1).

## Distribution

US Nationwide distribution in the state of Florida.

## Key facts

- **Recall number:** Z-0102-2023
- **Recalling firm:** ARROW INTERNATIONAL Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-09-14
- **Report date:** 2022-10-26
- **Termination date:** 2024-01-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Morrisville, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0102-2023

## Citation

> AI Analytics. FDA recall Z-0102-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0102-2023. Source: US FDA. Licensed CC0.

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