Cascade IOMAX Cortical Module, REF: 190296-200
FDA Device Recall #Z-1882-2024 — Class II — April 23, 2024
Recall Summary
| Recall Number | Z-1882-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 23, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Cadwell Industries Inc |
| Location | Kennewick, WA |
| Product Type | Devices |
| Quantity | 54 units |
Product Description
Cascade IOMAX Cortical Module, REF: 190296-200
Reason for Recall
There is the potential that an electroneurodiagnostic medical device insulator may be installed incorrectly which could result in arcing to patient connections resulting in potential unintended shock to the patient.
Distribution Pattern
Worldwide - US Nationwide distribution in the state of MD and the countries of Mexico, Canada, Malaysia, India, Taiwan, Saudi Arabia, European Union, Switzerland, South Africa, Iraq, United Kingdom.
Lot / Code Information
UDI-DI: 00840067100653/ Serial numbers: 19029603AA1223002 19029603AA1223003 19029603AA1223004 19029603AA1223005 19029603AA1223006 19029603AA1223007 19029603AA1223011 19029603AA1223012 19029603AA1223013 19029603AA1223014 19029603AA1223015 19029603AA1223016 19029603AA1223017 19029603AA1223018 19029603AA1223019 19029603AA1223020 19029603AA1223024 19029603AB1223021 19029603AB1223023 19029603AA1223025 19029603AA0124001 19029603AA0124002 19029603AA0224008 19029603AA0124007 19029603AA0124012 19029603AA0124017 19029603AA0124004 19029603AA0124010 19029603AA0124016 19029603AA0224010 19029603AA0124015 19029603AA1223026 19029603AA0124008 19029603AA0124009 19029603AA1223027 19029603AA1223028 19029603AA1223029 19029603AA0124003 19029603AA0224001 19029603AA1223030 19029603AA1223008 19029603AA1223009 19029603AA0124013 19029603AA1223031 19029603AA1223001 19029603AA0224002 19029603AA0224003 19029603AA0224004 19029603AA0224005 19029603AA0224006 19029603AA0224007 19029603AA0124014 19029603AA0224009 19029603AA0124011
Other Recalls from Cadwell Industries Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2349-2024 | Class II | Cascade IOMAX Cortical Module, REF: 190296-200 | May 17, 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.