Arrow¿ Two-Lumen Central Venous Catheterization Kit with Blue FlexTip¿ Catheter Product Code: A...

FDA Device Recall #Z-1118-2019 — Class II — January 10, 2019

Recall Summary

Recall Number Z-1118-2019
Classification Class II — Moderate risk
Date Initiated January 10, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Arrow International Inc
Location Reading, PA
Product Type Devices
Quantity None (US)

Product Description

Arrow¿ Two-Lumen Central Venous Catheterization Kit with Blue FlexTip¿ Catheter Product Code: AH-11802 (OUS) GTN: 00801902026132

Reason for Recall

The product lidstock contains a labelling error. The lidstock states the incorrect priming volume. The priming volumes printed on the extension lines are correct

Distribution Pattern

FL, NC

Lot / Code Information

Lot Numbers: 71F14E0696 71F14K0658 71F15E0493 71F15L0621 71F14E1541 71F14K1683 71F15F0090 71F15M0787 71F14F1154 71F14L0719 71F15H0574 71F16A0278 71F14H0474 71F14M1375 71F15H1503 71F16B0054 71F14H1215 71F15A0025 71F15J0570 71F16B1306 71F14J0852 71F15A1592 71F15J2098 71F14J1889 71F15D1460 71F15L0153

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.