Arrow PICC with Chlorag+ard Technology The ArrowEVOLUTION Pressure Injectable PICC with Chlorag+...

FDA Device Recall #Z-2286-2017 — Class II — March 20, 2017

Recall Summary

Recall Number Z-2286-2017
Classification Class II — Moderate risk
Date Initiated March 20, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Arrow International Inc
Location Reading, PA
Product Type Devices
Quantity unknown-firm reports total devices distributed 43,394

Product Description

Arrow PICC with Chlorag+ard Technology The ArrowEVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring

Reason for Recall

Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.

Distribution Pattern

Nationwide Distribution

Lot / Code Information

Material number CDA-44041-HPK1A

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.