Graphic Controls recalls CLARAVUE Pre-wired Electrode IP SET M3 RT ADULT-US Model 32028777. Defibrillation may be ineffective due to electrical charge issues. Affected units have UDI: 03700506307340.
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 M3 RT ADULT-US Model 32028777 because it may not deliver an effective electrical charge during defibrillation. This could lead to ineffective treatment in emergency situations.
The electrode does not meet the required electrical standards for defibrillation. When used with a defibrillator at high voltage, it may deliver an inefficient electrical charge, potentially causing ineffective defibrillation attempts.
Medical professionals using this electrode for defibrillation in emergency settings. Patients receiving defibrillation treatment with this specific model are at risk.
Check for the model number 32028777 on the product. The unique device identifier (UDI) is 03700506307340. This product was sold in the US.
Look for the unique device identifier (UDI) 03700506307340 on the product.
Reach out to Graphic Controls for guidance on next steps.
The electrode does not meet the required electrical standards for defibrillation. When used with a defibrillator at high voltage, it may deliver an inefficient electrical charge, potentially causing ineffective defibrillation attempts.
Check for the model number 32028777 and unique device identifier (UDI) 03700506307340 on the product. This product was sold in the US.
Contact Graphic Controls for guidance on next steps.
We’ve drafted a message you can send Graphic Controls to request your refund or repair — edit it as you like.
Subject: Recall Z-0936-2022 — Graphic Controls Graphic Controls Hello, I own a Graphic Controls that is covered by recall Z-0936-2022 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.
