BEUDAMED
    FDA Enforcement Class II Terminated

    LMA Esophageal Intubation Detector (EID), Catalog Number EID100 The device is used to assist verification of placement of the endotracheal tube or esophageal/tracheal double lumen tube. This device is to be used as an adjunct to assess intubation. Its purpose is not to eliminate clinical judgment

    Recall: Z-2022-2012 · Reported July 25, 2012

    Enforcement

    Recall Number
    Z-2022-2012
    Event ID
    62337
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    LMA North America Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 25, 2012
    Initiation Date
    May 23, 2012
    Classification Date
    July 17, 2012
    Termination Date
    December 26, 2012
    Address
    4660 La Jolla Village Dr Ste 900, San Diego, CA, 92122-4608, United States

    Description

    LMA Esophageal Intubation Detector (EID), Catalog Number EID100 The device is used to assist verification of placement of the endotracheal tube or esophageal/tracheal double lumen tube. This device is to be used as an adjunct to assess intubation. Its purpose is not to eliminate clinical judgment

    Reason

    The recall was initiated because LMANA has received a complaint that the Esophageal Intubation Detector (EID100) has a potential to create a false positive if used on a patient during confirmation of intubation.

    Code Info

    2009 Lot # 90923A, 91222A. 2010 Lot# 00327A, 00518A, 00623A, 00831B, 01013A, 01103A, 01214A. 2011 Lot# 10110A, 10301B, 10423A, 10530A, 10602A, 10703A, 10804A, 11004A. 2012 Lot# 120104, 120414.

    Distribution

    Worldwide Distribution--USA (nationwide) and the countries of Canada, United Kingdom, ZA, and Australia.

    Quantity

    18,799 units