FDA-Device2012-07-25Class II
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
LMA North America Inc
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.
Sold states
Worldwide Distribution--USA (nationwide) and the countries of Canada, United Kingdom, ZA, and Australia.
Affected count
18,799 units
Manufactured in
4660 La Jolla Village Dr Ste 900, San Diego, CA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2022-2012Don't want to check this manually?
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