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U.S. Department of Health and Human Services

Enforcement Report - Week of July 25, 2012

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Event Detail

Event ID 62337
Product Type Devices
Status Completed
Recalling Firm LMA North America Inc
City San Diego
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-23
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution--USA (nationwide) and the countries of Canada, United Kingdom, ZA, and Australia.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 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. Class II 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. 18,799 units Z-2022-2012