Halo One 5F Introducer Sheath 10 cm 5 pack Product Code: HAL510F Product Usage: The Halo One...
FDA Device Recall #Z-0970-2017 — Class I — December 2, 2016
Recall Summary
| Recall Number | Z-0970-2017 |
| Classification | Class I — Serious risk |
| Date Initiated | December 2, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | BARD PERIPHERAL VASCULAR, INC |
| Location | Tempe, AZ |
| Product Type | Devices |
| Quantity | 101 |
Product Description
Halo One 5F Introducer Sheath 10 cm 5 pack Product Code: HAL510F Product Usage: The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheath and introducer sheath. The Halo One Thin-Walled Guiding Sheath is indicated for use in peripheral arterial and venous procedures requiring percutaneous introduction of intravascular devices. The Halo One Thin-Walled Guiding Sheath is NOT indicated for use in the neurovasculature nor the coronary vasculature.
Reason for Recall
Complaints of sheath separation, kinking, and/or tip damage during use.
Distribution Pattern
Nationwide Distribution to NY, MO, NY, NY, FL, KS, MI, TX, NV, OH, ME, WA, LA, AZ, UT, NH. No foreign distribution.
Lot / Code Information
Product Code Lot Number UDI Number Quantity HAL510F 50137866 (01)00801741129698(17)170331(10)50137866 58 HAL510F 50137924 (01)00801741129698(17)170331(10)50137924 73 HAL510F 50138170 (01)00801741129698(17)170331(10)50138170 89 HAL510F 50138765 (01)00801741129698(17)170531(10)50138765 27
Other Recalls from BARD PERIPHERAL VASCULAR, INC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0969-2017 | Class I | Halo One 5F Introducer Sheath 90 cm Product Co... | Dec 2, 2016 |
| Z-0968-2017 | Class I | Halo One 5F Introducer Sheath 45 cm Product Co... | Dec 2, 2016 |
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.