Class 2 Device Recall Novaplus

• Date Initiated by Firm: September 15, 2020
• Create Date: November 05, 2020
• Recall Status: Terminated on February 01, 2022
• Recall Number: Z-0420-2021
• Recall Event ID: 86519
• 510(K)Number: K970796
• Product Classification: Electrode, electrocardiograph - Product Code DRX
• Product: Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 3 electrodes per card; 1 card per pouch; 200 pouches per shipper box (600 electrodes total).
• Code Information: Cat. No. V2560-3 (SKU: 70-2011-8380-6, SAP #: 7100205820). GTIN: 10707387788169 (pouch); 50707387788167 (shipper) Lots: 202201EB (Expiration 2022-01-01)
• Recalling Firm/ Manufacturer: 3M Company - Health Care Business; 3m Center 2510 Conway Ave; Bldg 275-5W-06; Saint Paul MN 55144-0001
• For Additional Information Contact: Naomi Rodiles; 651-733-1110
• Manufacturer Reason for Recall: Corrosion could cause performance failures in the product.
• FDA Determined Cause: Process control
• Action: The recalling firm issued customer letters to consignees on 10/7-8/2020. The recalling firm is requesting a returned acknowledgement form from the consignee. Distributors will also be sent a template customer letter and customer acknowledgement so that they may notify their customers. The recalling firm will initiate multiple attempts to follow up with non responders. Customers and distributors are requested to dispose of any products still in their possession.
• Quantity in Commerce: 156,600 units
• Distribution: Worldwide distribution - US Nationwide distribution and the countries of Europe (Austria, Belgium, Switzerland, Germany, Spain, Finland, France, Greece, Ireland, Italy, Netherlands, Norway, Portugal, Sweden) and Worldwide (China, Taiwan, Singapore, Indonesia, Japan, Mexico, Peru, Costa Rica, Canada).
• 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 = DRX