Recalled CLARAVUE Pre-wired Electrode Set May Fail During Defibrillation
Graphic Controls is recalling CLARAVUE Pre-wired Electrode sets because they fail to meet electrical safety specifications for defibrillators, potentially delivering inadequate charge during emergency treatment.
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 is an FDA Class II recall of a cardiac defibrillation device that fails to meet electrical safety specifications (5,000V DC withstand requirement). The failure could result in ineffective defibrillation during emergency cardiac treatment. No illnesses or injuries have been reported in the source material. Per the rubric, risk-of-harm products without reported injury score 3 (High).
Plain-English summary
Graphic Controls Acquisition Corporation is recalling CLARAVUE Pre-wired Electrode - IP SET M3 RT ADULT-US (Model 32028777 50600 US). All lot numbers are affected. The device is distributed nationwide across Arkansas, California, Colorado, Florida, Indiana, Kansas, Massachusetts, Minnesota, New York, Oklahoma, and Vermont, with 560 units involved in this recall.
The device's Instructions for Use state compliance with ANSI/AAMI EC53:2013/(R)2020 standards for ECG trunk cables and patient leadwires. Section 5.3.9 of this standard requires the device to withstand 5,000 volts DC without breakdown when used with a defibrillator operating above its maximum voltage threshold. However, the CLARAVUE device does not meet this specification.
Because the device fails to meet the electrical safety specification, it delivers an inefficient electrical charge. This may result in ineffective defibrillation, meaning patients may not receive adequate electrical therapy during emergency cardiac treatment.
The recalled product
- Product
- CLARAVUE Pre-wired Electrode - IP SET M3 RT ADULT-US Model: 32028777 50600 US
- Manufacturer
- Graphic Controls Acquisition Corporation
- Hazard
- electrical-safety-failure
- ineffective-defibrillation
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: 03700506307340
Distribution
Distributed nationwide across the United States.
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