Graphic Controls recalls CLARAVUE Pre-wired Electrode IP SET 12 RT ADULT-US Model 32028779 50602-US due to potential ineffective defibrillation when used with defibrillators. Affected units have UDI: 03700506307326.
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 12 RT ADULT-US models 32028779 and 50602-US because they may not deliver an effective electrical charge during defibrillation. This could lead to ineffective treatment in cardiac emergencies.
The electrodes do not meet the required electrical safety standard (ANSI/AAMI EC53:2013) for withstanding high voltage during defibrillation. When used with defibrillators at voltages above their maximum threshold, they may deliver an inefficient electrical charge, potentially causing ineffective defibrillation.
Medical professionals using this electrode during defibrillation procedures are most at risk. Patients receiving defibrillation treatment with this model may face ineffective cardiac shock.
Check for the model number 32028779 or 50602-US on the product label. Affected units have a Unique Device Identifier (UDI) of 03700506307326.
Look for the model number 32028779 or 50602-US and UDI 03700506307326 on the device.
The electrodes do not meet the required electrical safety standard for withstanding high voltage during defibrillation, which may result in ineffective defibrillation.
Check the product label for the model number 32028779 or 50602-US and UDI 03700506307326. If you have the affected model, contact Graphic Controls for guidance.
The recall is due to potential ineffective defibrillation during cardiac emergencies, which could lead to serious health risks if the device fails to deliver an effective shock.
We’ve drafted a message you can send Graphic Controls to request your refund or repair — edit it as you like.
Subject: Recall Z-0938-2022 — Graphic Controls Graphic Controls Hello, I own a Graphic Controls that is covered by recall Z-0938-2022 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.
