BEUDAMED
    FDA Recall Open, Classified

    NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) REF 8229306

    Recall: Z-1520-2022 · Initiated April 29, 2022

    Recall

    Recall Number
    Z-1520-2022
    Event Number
    90711
    Firm
    Medtronic Xomed, Inc.
    FEI Number
    1045254
    Product Code
    ETN
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    April 29, 2022
    Posted
    September 1, 2022
    Address
    6743 Southpoint Dr N, Jacksonville, FL, 32216-6218

    Description

    NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) REF 8229306

    Reason

    The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.

    Action

    Medtronic sent an URGENT: MEDICAL DEVICE SAFETY NOTICE to impacted customers on 29-APR-2022 by mail. The letter explained the problem and provided Recommended Actions when using NIM Standard Reinforced EMG Endotracheal Tube & NIM CONTACT" Reinforced EMG Endotracheal Tube and airway obstruction is encountered. Medtronic posted this issue to its US Product Performance and Advisories Information for Healthcare Professionals website on 3-May-2022. If you have any questions, contact your Medtronic ENT representative. Within the US, beginning 30-Jan-2024, Medtronic distributed a follow-up a notice via mail courier to all impacted consignees about availability of the updated IFU. On about 07/08/2024, Medtronic distributed an additional notification to consignees to notify them to remove all lots of the NIM Contact" EMG Reinforced Endotracheal Tubes and NIM" (Standard) EMG Reinforced Endotracheal Tubes. Customers were instructed to not use the affected devices and to identify, segregate, quarantine, and return affected products to Medtronic using the Customer Confirmation Form. https://www.medtronic.com/content/dam/medtronic-wide/public/united-states/products/ear-nose-throat/nim-contact-emg-reinforced-endotracheal-tubes.pdf.

    Distribution

    Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Germany, Greece, Hong Kong, Hungary, Iceland, India, Iran, Islamic Republic Of, Ireland, Israel, Italy, Japan, Korea, Republic Of, Kosovo, Kuwait, Libya, Lithuania, Luxembourg, Mexico, Netherlands, New Zealand, North Macedonia, Northern Mariana Islands, Norway, Oman, Panama, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Slovakia, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Viet Nam

    Quantity

    1,133,612 units