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Graphic Controls Acquisition Corporation Recall 89810

Description: CLARAVUE Pre-wired Electrode - IP SET 12 RT ADULT-US Model: 32028779 50602-US

Graphic Controls Acquisition Corporation Recall 89810 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0938-2022
Event ID89810
Event DescriptionCLARAVUE Pre-wired Electrode - IP SET 12 RT ADULT-US Model: 32028779 50602-US
Product TypeDevices
DistributionUS Nationwide distribution in the States of AR, CA, CO, FL, IN, KS, MA, MN, NY, OK, VT.
Quantity8265 units
Recall ReasonInstructions 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.
Device Classification20220420
Device Code InfoAll lots UDI: 03700506307326
Center Classification Date20220414
Recall Initiation Date20220315
Recalling FirmGraphic Controls Acquisition Corporation
Initial Notification E-Mail
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