Recall Z-0935-2022— Graphic Controls Acquisition Corporation
Class II · Terminated
Class II FDA medical device recall by Graphic Controls Acquisition Corporation, initiated 2022-03-15, terminated 2024-07-12. It names one FDA 510(k) clearance: K101685. Product: CLARAVUE Pre-wired Electrode IP-SET N3 - PEDIATRIC-US Model: 32028776 50401-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..
- Recalling firm
- Graphic Controls Acquisition Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-03-15
- Terminated
- 2024-07-12
- Firm location
- Buffalo, NY, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
CLARAVUE Pre-wired Electrode IP-SET N3 - PEDIATRIC-US Model: 32028776 50401-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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.