Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy, Product Cod...

FDA Device Recall #Z-1374-2021 — Class II — March 8, 2021

Recall Summary

Recall Number Z-1374-2021
Classification Class II — Moderate risk
Date Initiated March 8, 2021
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Arrow International Inc
Location Reading, PA
Product Type Devices
Quantity 3,756 units (US); 249 units (OUS) Expanded 810 units: 774 US and 36 OUS

Product Description

Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy, Product Code: 9464-VC-006 (US) Product Code: 9464-EU-001 (sold in European Regions only) - Product Usage: intended for bone biopsy of the vertebral body and bone lesions.

Reason for Recall

Difficulty inserting the biopsy ejector rod into the bone lesion biopsy cannula, preventing the biopsy sample from being collected. Use of a defective device is likely to require immediate repeat biopsy, leading to a prolonged procedure

Distribution Pattern

US Nationwide distribution.

Lot / Code Information

Lot Numbers US: 39647326 39647327 39647328 40422734 40422735 Lot Number: 40808740 (EU) EXPANDED RECALL: 5/4/21 Lot Numbers: 38347967 40422740

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.