BEUDAMED
    FDA Recall Terminated

    3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 50 electrodes per pouch; 20 pouches per shipper box (1000 electrodes total).

    Recall: Z-0422-2021 · Initiated September 15, 2020

    Recall

    Recall Number
    Z-0422-2021
    Event Number
    86519
    Firm
    3M Company Health Care Business 3m Center
    FEI Number
    2110898
    Product Code
    DRX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 15, 2020
    Terminated
    February 1, 2022
    Address
    2510 Conway Ave, Bldg 275-5W-06, Saint Paul, MN, 55144-0001

    Description

    3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 50 electrodes per pouch; 20 pouches per shipper box (1000 electrodes total).

    Reason

    Corrosion could cause performance failures in the product.

    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.

    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

    10,145,050 units