BEUDAMED
    FDA Enforcement Class II Terminated

    Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 5 electrodes per card; 1 card per pouch; 200 pouches per shipper box (1000 electrodes total).

    Recall: Z-0419-2021 · Reported November 11, 2020

    Enforcement

    Recall Number
    Z-0419-2021
    Event ID
    86519
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    3M Company - Health Care Business
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 11, 2020
    Initiation Date
    September 15, 2020
    Classification Date
    November 5, 2020
    Termination Date
    February 1, 2022
    Address
    3m Center 2510 Conway Ave, Bldg 275-5W-06, Saint Paul, MN, 55144-0001, United States

    Description

    Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 5 electrodes per card; 1 card per pouch; 200 pouches per shipper box (1000 electrodes total).

    Reason

    Corrosion could cause performance failures in the product.

    Code Info

    Cat. No. V2560-5 (SKU: 70-2011-8381-4, SAP #: 7100205978). GTIN: 10707387788176 (pouch) and 50707387788174 (shipper) Lots: 202112EQ (Expiration 2021-12-09); 202201EA (Expiration 2022-01-01); 202205EH (Expiration 2022-05-14); and 202205EI (Expiration 2022-05-19)

    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).

    Quantity

    1,572,000 units