Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CLARAVUE Pre-wired Electrode - IP SET M5 RT ADULT-US Model: 32028778 50601-US Recalled by Graphic Controls Acquisition Corporation Due to Instructions for Use (IFU) (Instructions for Use) indicate...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Graphic Controls Acquisition Corporation directly.
Affected Products
CLARAVUE Pre-wired Electrode - IP SET M5 RT ADULT-US Model: 32028778 50601-US
Quantity: 19470 units
Why Was This Recalled?
Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to withstand, without breakdown , an application of, 5,000 V d.c. when used with a defibrillator at a voltage above its maximum threshold, Claravue does not meet the specification and delivers an inefficient electrical charge which may result in an ineffective defibrillation.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Graphic Controls Acquisition Corporation
Graphic Controls Acquisition Corporation has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report