Recall Z-0938-2022
Graphic Controls Acquisition Corporation · initiated March 15, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
CLARAVUE Pre-wired Electrode - IP SET 12 RT ADULT-US Model: 32028779 50602-US
Codes / lots: All lots UDI: 03700506307326
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.
FDA-determined cause: Device Design
Action taken
Graphic Controls (d/b/a Nissha Medical Technologies/Vermed/Biomedical Innovations) issued Urgent Field Correction letter via email on 3/4/22. Letter states reason for recall, health risk and action to take: Section 5.1.5 of the standard provides that trunk cables and patient leadwires may be permanently marked to indicate they are not defibrillation proof. Immediately examine your inventory and complete the provided form Claravue IP Set Correction Notice Acknowledgement Form and return to claravue@nisshamedical.com If you have product in inventory our team will arrange for it to be returned and exchanged for product labeled correctly once available. In addition, if you may have further distributed this product, please identify your customer and notify them at once of this product correction. Your notification may be enhanced by including a copy of this correction letter. Please complete and return the attached form via e-mail to jpotter@nisshamedical.com as soon as possible. If you have any questions about this notice, please contact: Ms. Jessica Potter, Vice President Quality and Regulatory Nissha Medical Technologies, 400 Exchange Street, Buffalo, NY 14204, USA Phone: (716) 849-6367 E-Mail: jpotter@nisshamedical.com
Details
- Recall number
- Z-0938-2022
- Initiated
- March 15, 2022
- Terminated
- July 12, 2024
- Product code
- DRX – Electrode, Electrocardiograph
- Quantity
- 8265 units
- Distribution
- US Nationwide distribution in the States of AR, CA, CO, FL, IN, KS, MA, MN, NY, OK, VT.
- Recalling firm
- Graphic Controls Acquisition Corporation, Buffalo, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0935-2022 Class II | CLARAVUE Pre-wired Electrode IP-SET N3 - PEDIATRIC-US Model: 32028776 50401-USInstructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG… | 03/15/2022Terminated |
| Z-0936-2022 Class II | CLARAVUE Pre-wired Electrode - IP SET M3 RT ADULT-US Model: 32028777 50600 USInstructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG… | 03/15/2022Terminated |
| Z-0937-2022 Class II | CLARAVUE Pre-wired Electrode - IP SET M5 RT ADULT-US Model: 32028778 50601-USInstructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG… | 03/15/2022Terminated |
| Z-0939-2022 Class II | CLARAVUE Pre-wired Electrode - IP SET 6V RT ADULT-US Model: 32028780 50603-USInstructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG… | 03/15/2022Terminated |
| Z-0940-2022 Class II | CLARAVUE Pre-wired Electrode - IP SET 5V RT ADULT Model: 32028781 50604-USInstructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG… | 03/15/2022Terminated |