Home / Recalls / Graphic Controls Acquisition Corporation / Z-0939-2022

Z-0939-2022 Class II Terminated

Recalled by Graphic Controls Acquisition Corporation — Buffalo, NY

Recall Details

Product Type
Devices
Report Date
April 20, 2022
Initiation Date
March 15, 2022
Termination Date
July 12, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

CLARAVUE Pre-wired Electrode - IP SET 6V RT ADULT-US Model: 32028780 50603-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.

Distribution Pattern

US Nationwide distribution in the States of AR, CA, CO, FL, IN, KS, MA, MN, NY, OK, VT.

Code Information

All lots UDI: 03700506307319

Other recalls by Graphic Controls Acquisition Corporation

  • Z-0936-2022 Class II — CLARAVUE Pre-wired Electrode - IP SET M3 RT ADULT-US Model: 32028777 50600 US (March 15, 2022)
  • Z-0937-2022 Class II — CLARAVUE Pre-wired Electrode - IP SET M5 RT ADULT-US Model: 32028778 50601-US (March 15, 2022)
  • Z-0940-2022 Class II — CLARAVUE Pre-wired Electrode - IP SET 5V RT ADULT Model: 32028781 50604-US (March 15, 2022)
  • Z-0938-2022 Class II — CLARAVUE Pre-wired Electrode - IP SET 12 RT ADULT-US Model: 32028779 50602-US (March 15, 2022)
  • Z-0935-2022 Class II — CLARAVUE Pre-wired Electrode IP-SET N3 - PEDIATRIC-US Model: 32028776 50401-US (March 15, 2022)