Graphic Controls recalls Claravue Pre-wired Electrode IP SET 5V RT ADULT Model 32028781 50604-US due to potential ineffective defibrillation during use with defibrillators.
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.
Graphic Controls is recalling Claravue Pre-wired Electrode IP SET 5V RT ADULT models 32028781 and 50604-US. These devices may not deliver an effective electrical charge during defibrillation, risking ineffective treatment in emergencies.
The electrodes do not meet the required electrical safety standard for withstanding 5,000 volts during defibrillation. This can lead to inefficient electrical charges that may not properly treat cardiac arrhythmias.
Healthcare professionals using defibrillators with these electrodes may be at risk during cardiac emergencies. Patients receiving defibrillation treatment with these electrodes could experience ineffective treatment.
Check for the model number 32028781 or 50604-US on the device. The product was sold with a unique identifier (UDI) starting with 03700506307302.
Look for the model number 32028781 or 50604-US on the device label.
Reach out to Graphic Controls for specific guidance on handling the recalled product.
The electrodes may not deliver an effective electrical charge during defibrillation, potentially leading to ineffective treatment of cardiac emergencies.
Check for the model number 32028781 or 50604-US on the device, and the unique identifier (UDI) starting with 03700506307302.
Contact Graphic Controls for specific guidance on handling the recalled product.
We’ve drafted a message you can send Graphic Controls to request your refund or repair — edit it as you like.
Subject: Recall Z-0940-2022 — Graphic Controls Graphic Controls Hello, I own a Graphic Controls that is covered by recall Z-0940-2022 from Graphic Controls. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
