# FDA recall Z-0940-2022

> **Graphic Controls Acquisition Corporation** · Class II · device recall initiated 2022-03-15.

## Product

CLARAVUE Pre-wired Electrode -  IP SET 5V RT ADULT  Model:  32028781 50604-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

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

## Key facts

- **Recall number:** Z-0940-2022
- **Recalling firm:** Graphic Controls Acquisition Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-03-15
- **Report date:** 2022-04-20
- **Termination date:** 2024-07-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Buffalo, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0940-2022

## Citation

> AI Analytics. FDA recall Z-0940-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0940-2022. Source: US FDA. Licensed CC0.

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