PlainRecalls
FDA Devices Moderate Class II Terminated

CLARAVUE Pre-wired Electrode - IP SET M3 RT ADULT-US Model: 32028777 50600 US

Reported: April 20, 2022 Initiated: March 15, 2022 #Z-0936-2022

Product Description

CLARAVUE Pre-wired Electrode - IP SET M3 RT ADULT-US Model: 32028777 50600 US

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.

Details

Units Affected
560 units
Distribution
US Nationwide distribution in the States of AR, CA, CO, FL, IN, KS, MA, MN, NY, OK, VT.
Location
Buffalo, NY

Frequently Asked Questions

What product was recalled? ▼
CLARAVUE Pre-wired Electrode - IP SET M3 RT ADULT-US Model: 32028777 50600 US. Recalled by Graphic Controls Acquisition Corporation. Units affected: 560 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 20, 2022. Severity: Moderate. Recall number: Z-0936-2022.

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