Cascade IOMAX Cortical Module, REF: 190296-200
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI: 00840067100653/Serial Numbers:19029603AA0224001, 19029603AA0224002, 19029603AA0224003, 19029603AA0224004,19029603AA0224005, 19029603AA0224006, 19029603AA0224007, 19029603AA0224008, 19029603AA0224010, 19029603AA0224021, 19029603AA0224027, 19029603AA0324006, 19029603AA0324007, 19029603AA0324008, 19029603AA0324009, 19029603AA0324010, 19029603AA0424001, 19029603AA0424002, 19029603AA0424003, 19029603AA0424006, 19029603AA0424007, 19029603AA0424008, 19029603AA0424009, 19029603AA0424010, 19029603AA0524003, 19029603AA0524004
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Cadwell Industries Inc
- Reason for Recall:
- Electroneurodiagnostic medical device may contain a defective printed circuit board which may cause damage to the other internal components resulting in unintended electrical stimulation.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Cascade IOMAX Cortical Module, REF: 190296-200
Product Codes/Lot Numbers:
UDI: 00840067100653/Serial Numbers:19029603AA0224001, 19029603AA0224002, 19029603AA0224003, 19029603AA0224004,19029603AA0224005, 19029603AA0224006, 19029603AA0224007, 19029603AA0224008, 19029603AA0224010, 19029603AA0224021, 19029603AA0224027, 19029603AA0324006, 19029603AA0324007, 19029603AA0324008, 19029603AA0324009, 19029603AA0324010, 19029603AA0424001, 19029603AA0424002, 19029603AA0424003, 19029603AA0424006, 19029603AA0424007, 19029603AA0424008, 19029603AA0424009, 19029603AA0424010, 19029603AA0524003, 19029603AA0524004
Distribution:
Distributed in: US, IL, CA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2349-2024
Related Recalls
Cascade IOMAX Cortical Module, REF: 190296-200
Cadwell Industries
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.