Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit Recalled by ARROW INTERNATIONAL Inc. Due to Mislabeling

Date: September 14, 2022
Company: ARROW INTERNATIONAL Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact ARROW INTERNATIONAL Inc. directly.

Affected Products

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.

Quantity: 18 devices

Why Was This Recalled?

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).

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About ARROW INTERNATIONAL Inc.

ARROW INTERNATIONAL Inc. has 47 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report