Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow...

FDA Device Recall #Z-0004-2024 — Class I — August 10, 2023

Recall Summary

Recall Number Z-0004-2024
Classification Class I — Serious risk
Date Initiated August 10, 2023
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm ARROW INTERNATIONAL Inc.
Location Morrisville, NC
Product Type Devices
Quantity 172 units

Product Description

Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet, REF CDC-45563-TTS; catheter, intravascular, therapeutic, long-term greater than 30 days

Reason for Recall

This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.

Distribution Pattern

US

Lot / Code Information

Batch/Lot number 13F22G0508

Other Recalls from ARROW INTERNATIONAL Inc.

Recall # Classification Product Date
Z-3299-2024 Class II Arrow Arterial Kits and Trays as follows: (1... Jul 26, 2024
Z-1879-2024 Class I Arrow UltraFlex Intra-Aortic Balloon Catheter K... Apr 29, 2024
Z-1880-2024 Class I Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter... Apr 29, 2024
Z-1878-2024 Class I Arrow FiberOptix Intra-Aortic Balloon Catheter ... Apr 29, 2024
Z-1267-2024 Class I ARROW QuickFlash Radial Artery Catherization (w... Feb 12, 2024

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.