Reported Jul 25, 2012 · Terminated
LMA Esophageal Intubation Detector (EID), Catalog Number EID100 The device is used to assist verification of placement…
LMA North America Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: LMA North America Inc · 4660 La Jolla Village Dr Ste 900 · San Diego, CA · 92122-4608
Is this the product you have?
- 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
- Lot codes and dates
2009 Lot # 90923A91222A. 2010 Lot# 00327A00518A00623A00831B01013A01103A01214A. 2011 Lot# 10110A10301B10423A10530A10602A10703A10804A11004A. 2012 Lot# 120104120414
- Amount recalled
- 18,799 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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