Z-0935-2022Class II

CLARAVUE Pre-wired Electrode IP-SET N3 - PEDIATRIC-US Model: 32028776 50401-US

Name: Z-0935-2022 CLARAVUE Pre-wired Electrode IP-SET N3 - PEDIATRIC-US Model: 32028776 50401-US
Creator: Graphic Controls Acquisition Corporation
Published: 2022-03-15
License: https://open.fda.gov/license/

Graphic Controls Acquisition Corp.dba Nissha Medical Technologies / initiated 2022-03-15 / Terminated / root cause: design

FDA source

Graphic Controls Acquisition Corporation began a recall of CLARAVUE Pre-wired Electrode IP-SET N3 - PEDIATRIC-US Model: 32028776 50401-US on 2022-03-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0935-2022
Classification: Class II
Status: Terminated
Initiated: 2022-03-15
Posted: 2022-04-14
Terminated: 2024-07-12
Recalling firm: Graphic Controls Acquisition Corp.dba Nissha Medical Technologies
Product: CLARAVUE Pre-wired Electrode IP-SET N3 - PEDIATRIC-US Model: 32028776 50401-US
Product code: DRX Electrode, Electrocardiograph
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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]
Quantity in commerce: 40 units
Distribution: US Nationwide distribution in the States of AR, CA, CO, FL, IN, KS, MA, MN, NY, OK, VT.
Product codes and lots: All lots UDI: 03700506307357

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0935-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0935-2022	Class II	Terminated	Voluntary: Firm initiated	2022-04-20	2022-04-14
Z-0936-2022	Class II	Terminated	Voluntary: Firm initiated	2022-04-20	2022-04-14
Z-0937-2022	Class II	Terminated	Voluntary: Firm initiated	2022-04-20	2022-04-14
Z-0938-2022	Class II	Terminated	Voluntary: Firm initiated	2022-04-20	2022-04-14
Z-0939-2022	Class II	Terminated	Voluntary: Firm initiated	2022-04-20	2022-04-14
Z-0940-2022	Class II	Terminated	Voluntary: Firm initiated	2022-04-20	2022-04-14

Product code DRX

K101685Class IIIp-SetIntegral Process Sas / cleared 2010-07-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)