Vermed recallZ-0938-2022 · Graphic Controls Acquisition Corporation · initiated Mar 15, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Graphic Controls Acquisition Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Device Design
What the company is doing
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 [email protected] 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 [email protected] 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: [email protected]
Recall details
- Recall number
- Z-0938-2022
- Status
- Terminated
- Initiated by the company
- Mar 15, 2022
- Recalling firm
- Graphic Controls Acquisition Corporation
- Quantity
- 8265 units
- Product code
- DRX
- FDA submissions
- K101685
- Distribution
- US Nationwide distribution in the States of AR, CA, CO, FL, IN, KS, MA, MN, NY, OK, VT.
Product description
CLARAVUE Pre-wired Electrode - IP SET 12 RT ADULT-US Model: 32028779 50602-US
Code information (models, lots, serial numbers)
All lots UDI: 03700506307326
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Vermed IP-Set 12 RT Adult-USGraphic Controls Acquisition Corp · Electrode, Electrocardiograph1 recall0 reports
Product lines
Other devices under the same FDA submission
5 devices cleared under K101685 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Vermed IP-Set 5V RT Adult-USGraphic Controls Acquisition Corp · Electrode, Electrocardiograph1 recall0 reports
- Vermed IP-Set 6V RT ADULT-USGraphic Controls Acquisition Corp · Electrode, Electrocardiograph1 recall0 reports
- Vermed IP-Set M5 RT Adult-USGraphic Controls Acquisition Corp · Electrode, Electrocardiograph1 recall0 reports
- Vermed IP-Set M3 RT Adult-USGraphic Controls Acquisition Corp · Electrode, Electrocardiograph1 recall0 reports
- Vermed IP-Set N3-Pediatric-USGraphic Controls Acquisition Corp · Electrode, Electrocardiograph1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 89810).
- Z-0935-2022 · TerminatedCLARAVUE Pre-wired Electrode IP-SET N3 - PEDIATRIC-US Model: 32028776 50401-US
- Z-0936-2022 · TerminatedCLARAVUE Pre-wired Electrode - IP SET M3 RT ADULT-US Model: 32028777 50600 US
- Z-0937-2022 · TerminatedCLARAVUE Pre-wired Electrode - IP SET M5 RT ADULT-US Model: 32028778 50601-US
- Z-0939-2022 · TerminatedCLARAVUE Pre-wired Electrode - IP SET 6V RT ADULT-US Model: 32028780 50603-US
- Z-0940-2022 · TerminatedCLARAVUE Pre-wired Electrode - IP SET 5V RT ADULT Model: 32028781 50604-US
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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