ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch...

FDA Device Recall #Z-0102-2023 — Class II — September 14, 2022

Recall Summary

Recall Number Z-0102-2023
Classification Class II — Moderate risk
Date Initiated September 14, 2022
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm ARROW INTERNATIONAL Inc.
Location Morrisville, NC
Product Type Devices
Quantity 18 devices

Product Description

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 Pattern

US Nationwide distribution in the state of Florida.

Lot / Code Information

UDI (01)10801902144284(17)230731(11)220504(10)13F22C0757

Other Recalls from ARROW INTERNATIONAL Inc.

Recall # Classification Product Date
Z-3299-2024 Class II Arrow Arterial Kits and Trays as follows: (1... Jul 26, 2024
Z-1880-2024 Class I Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter... Apr 29, 2024
Z-1879-2024 Class I Arrow UltraFlex Intra-Aortic Balloon Catheter K... Apr 29, 2024
Z-1878-2024 Class I Arrow FiberOptix Intra-Aortic Balloon Catheter ... Apr 29, 2024
Z-1267-2024 Class I ARROW QuickFlash Radial Artery Catherization (w... Feb 12, 2024

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.