LMA North America Inc: Medical Device Recall in 2012 - (Recall #: Z-2022-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 23, 2012

Date Posted: July 25, 2012

Recall Number: Z-2022-2012

Event ID: 62337

Reason for Recall:

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.

Status: Terminated

Product Quantity: 18,799 units

Code Information:

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.

Distribution Pattern:

Worldwide Distribution--USA (nationwide) and the countries of Canada, United Kingdom, ZA, and Australia.

Voluntary or Mandated:

Voluntary: Firm initiated