Arrow AGB+ Multi-Lumen CVC Kit, 7 Fr., 3 Lumen, 20cm catheter length, .025 inch dia. spring-wire ...
FDA Device Recall #Z-0468-2019 — Class II — September 21, 2018
Recall Summary
| Recall Number | Z-0468-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 21, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Arrow International Inc |
| Location | Reading, PA |
| Product Type | Devices |
| Quantity | 3640 |
Product Description
Arrow AGB+ Multi-Lumen CVC Kit, 7 Fr., 3 Lumen, 20cm catheter length, .025 inch dia. spring-wire guide, Product Code CDC-45703-B1A - Product Usage: The multiple-lumen catheter permits venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. The ARROWg+ard Blue Plus antimicrobial catheter is intended to help provide protection against catheter-related infections. It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use.
Reason for Recall
The products labeling contains inconsistencies. In certain instances, the lidstock, banner card and shipper label state that the Spring Wire Guide (SWG) within is .032 rather than the correct SWG size .025 . For other lots in scope the lidstock correctly states the SWG size .025 however the banner card states the incorrect SWG size .032 .
Distribution Pattern
US Nationwide distribution in the states of CA, FL, ID, IL, MI, NC, NJ, PA, and WI.
Lot / Code Information
Lot/Batch Numbers: 13F17E0685 13F17F0562 13F17H0141 13F17K0340 13F18B0119 13R17E0685
Other Recalls from Arrow International Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0231-2022 | Class I | Arrow-Trerotola Over-The-Wire PTD Kit Percutane... | Sep 20, 2021 |
| Z-0232-2022 | Class I | Arrow-Trerotola Over-The-Wire PTD Kit Percutane... | Sep 20, 2021 |
| Z-0234-2022 | Class I | Arrow-Trerotola Over-The-Wire PTD Kit Percutane... | Sep 20, 2021 |
| Z-0233-2022 | Class I | Arrow-Trerotola Over-The-Wire PTD Kit Percutane... | Sep 20, 2021 |
| Z-2071-2021 | Class II | Arrow Temporary Pacing Catheter/Introducer Kit ... | May 19, 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.