CLARAVUE Pre-wired Electrode - IP SET 5V RT ADULT Model: 32028781 50604-US
Check against the official notice below — it lists the full affected range.
Graphic Controls Acquisition Corporation is recalling the CLARAVUE Pre-wired Electrode - IP SET 5V RT ADULT Model 32028781 50604-US due to a safety defect. The device's Instructions for Use indicate it complies with ANSI/AAMI EC53:2013/(R)2020 standards for ECG trunk cables and patient leadwires. However, the device does not actually meet Section 5.3.9 of that standard, which requires the device to withstand an application of 5,000 volts DC without breakdown when used with a defibrillator operating above its maximum threshold.
Because the device fails to meet this requirement, it delivers an inefficient electrical charge that may result in an ineffective defibrillation. The recall affects all lots of this device (UDI: 03700506307302) distributed nationwide in Arkansas, California, Colorado, Florida, Indiana, Kansas, Massachusetts, Minnesota, New York, Oklahoma, and Vermont. The recall record does not specify what an affected consumer should do.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: US Nationwide distribution in the States of AR, CA, CO, FL, IN, KS, MA, MN, NY, OK, VT. Quantity: N/A Lot/code info: All lots UDI: 03700506307302
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.