Z-0936-2022 Class II Terminated
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
- 560 units
Product Description
CLARAVUE Pre-wired Electrode - IP SET M3 RT ADULT-US Model: 32028777 50600 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: 03700506307340