CLARAVUE Pre-wired Electrode — Class II medical device recall Z-0938-2022
Terminated recall by Graphic Controls Acquisition Corporation, reported 2022-04-20, distributed nationwide. Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG tru
| Recall number | Z-0938-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Graphic Controls Acquisition Corporation, Buffalo, NY, United States |
| Recall initiated | 2022-03-15 |
| Classified | 2022-04-14 |
| Reported by FDA | 2022-04-20 |
| Terminated | 2024-07-12 |
| Distributed | Nationwide (US) |
| Quantity | 8,265 units |
| UPC / GTIN / UDI-DI | 03700506307326 |
| Model numbers | 32028779, 50602-US |
Product
CLARAVUE Pre-wired Electrode - IP SET 12 RT ADULT-US Model: 32028779 50602-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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0938-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.