Clear Flashback Needle 7cm x 18G AMC/4; Clear Flashback Needle 2.5 cm x 21G AMC/4; Winged Arteria...
FDA Device Recall #Z-2252-2017 — Class II — May 11, 2017
Recall Summary
| Recall Number | Z-2252-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 11, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Argon Medical Devices, Inc |
| Location | Athens, TX |
| Product Type | Devices |
| Quantity | 7140 pieces |
Product Description
Clear Flashback Needle 7cm x 18G AMC/4; Clear Flashback Needle 2.5 cm x 21G AMC/4; Winged Arterial Needle 7cm x 18G AMC/4; Clear Flashback Needle 7 cm x 19G AMC/4 Usage: Argon Arterial Access Needles are designed to provide vascular access for the percutaneous introduction of a guidewire.
Reason for Recall
Argon Medical has received a complaint from one of their distributors of a potential packaging defect. The product is sealed in a pouch and the defect if present shows as a potential void or unsealed edge of the pouch.
Distribution Pattern
Worldwide Distribution - US Nationwide in the countries of Belgium, Canada, Japan, Netherlands
Lot / Code Information
11161099 11161729 11160990 11160912
Other Recalls from Argon Medical Devices, Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0589-2026 | Class II | Option"ELITE Vena Cava Filter System REF 352506... | Sep 12, 2025 |
| Z-3192-2024 | Class II | BioPince Ultra Full Core Biopsy Instrument: REF... | Jul 2, 2024 |
| Z-2638-2024 | Class II | L-CATH PICC S/L Peripherally Inserted Central C... | Jun 14, 2024 |
| Z-2239-2023 | Class II | Argon Medical Devices, REF 352506070E, Option E... | Jun 8, 2023 |
| Z-0563-2022 | Class II | 1. Arterial Line Kit 20ga x 6" 2. Arterial L... | Jan 24, 2022 |
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.