The Recall Desk
HighFDA (Devices)·Z-0938-2022·Announced 2022-04-20

Pre-wired ECG Electrode Set Fails Defibrillation Voltage Safety Standard

Graphic Controls' CLARAVUE Pre-wired Electrode set does not meet required electrical specifications for defibrillation use. The device fails to withstand 5,000 volts without breakdown, potentially resulting in ineffective defibrillation.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II recall involves a risk-of-harm product with no reported injuries or illnesses. The device's failure to withstand required voltage levels could compromise defibrillation effectiveness in life-critical cardiac emergencies.

Plain-English summary

Graphic Controls Acquisition Corporation is recalling the CLARAVUE Pre-wired Electrode - IP SET 12 RT ADULT-US (Model 32028779), a cardiac monitoring device used for ECG measurement. Approximately 8,265 units were distributed nationwide.

The device does not comply with the ANSI/AAMI EC53:2013/(R)2020 standard for ECG trunk cables and patient leadwires. It fails to withstand 5,000 volts direct current without breakdown when used with a defibrillator operating at or above its maximum voltage threshold. As a result, the device delivers an inefficient electrical charge.

This electrical performance failure may result in ineffective defibrillation during emergency cardiac care. The device has been distributed to healthcare facilities in Arkansas, California, Colorado, Florida, Indiana, Kansas, Massachusetts, Minnesota, New York, Oklahoma, and Vermont.

The recalled product

Product
CLARAVUE Pre-wired Electrode - IP SET 12 RT ADULT-US Model: 32028779 50602-US
Manufacturer
Graphic Controls Acquisition Corporation
Category
Medical Device — Cardiac Monitoring / Defibrillation
Hazard
Affected units
8,265

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots UDI: 03700506307326

Distribution

Distributed nationwide across the United States.

The notice also names 11 states specifically:

Part of a larger recall action

This product is one of 6 recalled by Graphic Controls Acquisition Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

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