Recall Z-1882-2024— Cadwell Industries Inc

Name: FDA recall Z-1882-2024
Creator: U.S. Food and Drug Administration
Published: 2024-04-23

Class II · Ongoing

Class II FDA medical device recall by Cadwell Industries Inc, initiated 2024-04-23. It names one FDA 510(k) clearance: K162199. Product: Cascade IOMAX Cortical Module, REF: 190296-200. Reason: 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..

Recalling firm: Cadwell Industries Inc
Classification: Class II
Status: Ongoing
Initiated: 2024-04-23
Firm location: Kennewick, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K162199 — Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.·cleared 2017-03-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.