FDAFDA · Food and drugs·Recall number Z-2022-2012
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
Published July 25, 2012 · Recall initiated: May 23, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- LMA North America Inc
- Distributor
- Worldwide Distribution--USA (nationwide) and the countries of Canada, United Kingdom, ZA, and Australia.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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