Graphic Controls recalls pediatric electrode sets that may not deliver effective defibrillation during cardiac emergencies, potentially causing ineffective shocks.
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 pediatric electrode sets that may not deliver effective defibrillation during cardiac emergencies. This could lead to ineffective shocks if used with defibrillators, risking patient safety.
The electrode sets may not withstand high voltage levels required during defibrillation. This can cause inefficient electrical charges, potentially leading to ineffective shocks when used with defibrillators.
Pediatric patients using defibrillators with these electrode sets. Parents and caregivers of children under 12 who use medical defibrillators are most at risk.
Check for the model number 32028776 50401-US on the product. The product has a unique identifier (UDI) starting with 03700506307357.
Look for the model number 32028776 50401-US and unique identifier starting with 03700506307357.
The electrode sets may not deliver effective defibrillation when used with defibrillators due to not meeting voltage withstand standards.
The recall record does not specify a remedy, so check with the manufacturer for further instructions.
The product may not deliver effective defibrillation during cardiac emergencies, so it should not be used with defibrillators.
We’ve drafted a message you can send Graphic Controls to request your refund or repair — edit it as you like.
Subject: Recall Z-0935-2022 — Graphic Controls Graphic Controls Hello, I own a Graphic Controls that is covered by recall Z-0935-2022 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.
