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Class 2 Device Recall CLARAVUE |
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Date Initiated by Firm |
March 15, 2022 |
Create Date |
April 14, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0935-2022 |
Recall Event ID |
89810 |
510(K)Number |
K101685
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Product Classification |
Electrode, electrocardiograph - Product Code DRX
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Product |
CLARAVUE Pre-wired Electrode IP-SET N3 - PEDIATRIC-US Model: 32028776 50401-US |
Code Information |
All lots
UDI: 03700506307357
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Recalling Firm/ Manufacturer |
Graphic Controls Acquisition Corporation 400 Exchange St Buffalo NY 14204-2064
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For Additional Information Contact |
Peter OLoughlin Vice President, General Manager 716-853-7500
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Manufacturer 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.
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FDA Determined Cause 2 |
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 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 |
Quantity in Commerce |
40 units |
Distribution |
US Nationwide distribution in the States of AR, CA, CO, FL, IN, KS, MA, MN, NY, OK, VT.
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Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database |
510(K)s with Product Code = DRX and Original Applicant = INTEGRAL PROCESS SAS
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