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LMA North America Inc recalls LMA Esophageal Intubation Detector (EID), Catalog Number EID100 The device is used to assist verification of placemen
Recalled July 25, 2012 · FDA recall Z-2022-2012 · LMA North America
Hazard
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. · FDA Class II
Units
18,799 units
Sold at
Worldwide Distribution--USA (nationwide) and the countries of Canada, United Kingdom, ZA, and Australia.
Description
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.
Product
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
Manufacturer(s)
LMA North America Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →