Graphic Controls Acquisition Corporation: Medical Device Recall in 2022 - (Recall #: Z-0935-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

CLARAVUE Pre-wired Electrode IP-SET N3 - PEDIATRIC-US Model: 32028776 50401-US

Product Classification:

Class II

Date Initiated: March 15, 2022

Date Posted: April 20, 2022

Recall Number: Z-0935-2022

Event ID: 89810

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.

Status: Terminated

Product Quantity: 40 units

Code Information:

All lots UDI: 03700506307357

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated