Recall archive / FDA device enforcement
CLARAVUE Pre-wired Electrode - IP SET 6V RT ADULT-US Model: 32028780 50603-US — FDA record Z-0939-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 15, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- CLARAVUE Pre-wired Electrode - IP SET 6V RT ADULT-US Model: 32028780 50603-US
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Graphic Controls Acquisition Corporation
- Quantity
- N/A
- Agency-reported status
- Terminated
- Source record identifier
- Z-0939-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | All lots UDI: 03700506307319 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution in the States of AR, CA, CO, FL, IN, KS, MA, MN, NY, OK, VT.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Apr 20, 2022
- Recall initiation date
- Mar 15, 2022
- Center classification date
- Apr 14, 2022
- Termination date
- Jul 12, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.