Cadwell Industries Inc recalls Cascade IOMAX Cortical Module, REF: 190296-200

Recall date

April 23, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1882-2024

FDA classification

Class II

Brand / firm

Cadwell Industries Inc

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Cascade IOMAX Cortical Module, REF: 190296-200