Class 2 Device Recall Disposable Monopolar and Subdermal Needle Electrodes

• Date Initiated by Firm: August 09, 2022
• Create Date: September 12, 2022
• Recall Status: Terminated on April 11, 2024
• Recall Number: Z-1737-2022
• Recall Event ID: 90733
• 510(K)Number: K130136
• Product Classification: Electrode, needle, diagnostic electromyograph - Product Code IKT
• Product: Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile.
• Code Information: Lot numbers 044220, exp. 1/1/2023; 045077, exp. 3/1/2023; 045443, exp. 4/1/2023; and 049285, exp. 7/1/2024; UDI-DI 08718375861530.
• Recalling Firm/ Manufacturer: Technomed Europe; Amerikalaan 71; Maastricht-Airport Netherlands
• For Additional Information Contact: Sanne Habets; 31 434 086868
• Manufacturer Reason for Recall: Burns of varying degrees can occur to patients with electrodes left in while in the MRI scanner as a result of inadequate safety information in the IFU.
• FDA Determined Cause: Labeling Change Control
• Action: The recalling firm issued letters dated 8/9/2022 that were flagged "MRI Safety Information." The letter provided an overview of the issue, the affected devices and lot numbers, a description of the issue including the MRI Safety Information that was added to the Instructions for Use, the hazard, and the actions to be taken. The actions included the consignee is to read the Field Safety Notice, review the list of affected products, inform customers who received or will receive products from the affected lot numbers about the issue by forwarding a copy of the notice and the updated Instructions for Use to them, and complete and sign the enclosed acknowledgment form to indicate they have read the notice, understand its content, and will follow the instructions as intended. The form is to be returned via email.
• Quantity in Commerce: 37/25-electrode boxes
• Distribution: US Nationwide distribution in the states of CA, FL, NH, OH, and WA.
• Total Product Life Cycle: TPLC Device Report

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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = IKT