1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"
FDA Device Recall #Z-0563-2022 — Class II — January 24, 2022
Recall Summary
| Recall Number | Z-0563-2022 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 24, 2022 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Argon Medical Devices, Inc |
| Location | Athens, TX |
| Product Type | Devices |
| Quantity | 600 ea |
Product Description
1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"
Reason for Recall
Guidewire included with two lots of Arterial Line Kits would not fit through the needle of the same kit. This could potentially lead to a slight delay in the procedure and minor blood loss.
Distribution Pattern
US Nationwide distribution in the states of AL, CA, DE, IL, IN, LA, MT, NV, OH, TX, VA, TN.
Lot / Code Information
1. Model: 400115A and Serial # 11377499, Expire Date: 10/27/2022 2. Model: 498100 and Serial # 11378381, Expire Date: 4/15/2026
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-0354-2022 | Class II | SuperCore Biopsy Instrument: REF/Product Des... | Oct 4, 2021 |
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.