Cadwell Industries Inc: Device Recall

Recall #Z-1882-2024 · 04/23/2024

Class II: Risk

Recall Details

Recall Number: Z-1882-2024
Classification: Class II
Product Type: Device
Recalling Firm: Cadwell Industries Inc
Status: Ongoing
Date Initiated: 04/23/2024
Location: Kennewick, WA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 54 units

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.

Product Description

Cascade IOMAX Cortical Module, REF: 190296-200

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.

Other Recalls by Cadwell Industries Inc

Class II: Risk 05/17/2024

Electroneurodiagnostic medical device may contain a defective printed circuit board which may cause damage to the other internal components resulting in unintended electrical stimulation.

View all recalls by Cadwell Industries Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.