Graphic Controls recalls CLARAVUE Pre-wired Electrode IP SET M5 RT ADULT-US Model 32028778 50601-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 M5 RT ADULT-US models because they may not deliver an effective electrical charge during defibrillation. This could lead to ineffective treatment in emergency situations.
The device fails to meet the required electrical standards for defibrillation. When used with a defibrillator at high voltage, it may not deliver an effective electrical charge, potentially leading to ineffective treatment during cardiac emergencies.
Healthcare professionals using the CLARAVUE Pre-wired Electrode for defibrillation procedures are most at risk. Patients receiving defibrillation using this device could face ineffective treatment.
Check for the model number 32028778 50601-US on the CLARAVUE Pre-wired Electrode. The product was sold with a unique identifier (UDI) starting with 03700506307333.
Look for the model number 32028778 50601-US on the CLARAVUE Pre-wired Electrode.
The device may not deliver an effective electrical charge during defibrillation when used with a defibrillator at high voltage, potentially leading to ineffective treatment.
The recall record does not specify a remedy, so contact the manufacturer for guidance.
The recall indicates a potential risk of ineffective defibrillation, so it is not recommended for use until the manufacturer provides further instructions.
We’ve drafted a message you can send Graphic Controls to request your refund or repair — edit it as you like.
Subject: Recall Z-0937-2022 — Graphic Controls Graphic Controls Hello, I own a Graphic Controls that is covered by recall Z-0937-2022 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.
