The CG+ Arrow PIC Catheters permit venous access to the central circulation through a peripheral ...

FDA Device Recall #Z-1705-2017 — Class II — March 3, 2017

Recall Summary

Recall Number Z-1705-2017
Classification Class II — Moderate risk
Date Initiated March 3, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Arrow International Inc
Location Reading, PA
Product Type Devices
Quantity 1,351 catheters

Product Description

The CG+ Arrow PIC Catheters permit venous access to the central circulation through a peripheral vein.

Reason for Recall

Arrow International, Inc. notified its customers who received the affected Antimicrobial/Antithrombogenic PICC Kits, that the kits were being recalled due to a labeling error. The lidstock on some of the kits reads CDC-45541-HPK1A, while the banner card on the side of the kit reads CDC-45052-HPK1A. Other kits may list CDC-45052-HPK1A on the lidstock and CDC-45541-HPK1A on the banner card. The affected lot numbers are 23F16C0851, 23F16A0727, and 23F16C0844.

Distribution Pattern

US Distribution

Lot / Code Information

Device Listing Number: D149129 Lot Numbers: 23F16C0851, 23F16A0727 and 23F16C0844

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.