CLARAVUE Pre-wired Electrode - IP SET M5 RT ADULT-US Model: 32028778 50601-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 M5 RT ADULT-US (Model: 32028778 50601-US) due to a safety issue with its electrical specifications. The device's Instructions for Use claim compliance with the ANSI/AAMI EC53:2013/(R)2020 standard for ECG trunk cables and patient leadwires, which requires the device to withstand 5,000 volts direct current without breakdown when used with a defibrillator operating above its maximum threshold. However, the CLARAVUE device does not meet this specification and delivers an inefficient electrical charge, which may result in ineffective defibrillation.
The recall affects 19,470 units distributed nationwide across Arkansas, California, Colorado, Florida, Indiana, Kansas, Massachusetts, Minnesota, New York, Oklahoma, and Vermont. All lots are included in this recall, identified by UDI: 03700506307333. The product recall record does not specify a remedy or action for affected consumers.
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: 19470 units Lot/code info: All lots UDI: 03700506307333
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.