Graphic Controls Acquisition Corporation Recall 89810
Description: CLARAVUE Pre-wired Electrode - IP SET M3 RT ADULT-US Model: 32028777 50600 US
Graphic Controls Acquisition Corporation Recall 89810 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0936-2022 |
| Event ID | 89810 |
| Event Description | CLARAVUE Pre-wired Electrode - IP SET M3 RT ADULT-US Model: 32028777 50600 US |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the States of AR, CA, CO, FL, IN, KS, MA, MN, NY, OK, VT. |
| Quantity | 560 units |
| Recall 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. |
| Device Classification | 20220420 |
| Device Code Info | All lots UDI: 03700506307340 |
| Center Classification Date | 20220414 |
| Recall Initiation Date | 20220315 |
| Recalling Firm | Graphic Controls Acquisition Corporation |
| Initial Notification | |
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