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.