Z-2022-2012Class II

LMA Esophageal Intubation Detector (EID), Catalog Number EID100 The device is used to assist verification of...

Name: Z-2022-2012 LMA Esophageal Intubation Detector (EID), Catalog Number EID100 The device is used to assist verification of...
Creator: LMA North America Inc
Published: 2012-05-23
License: https://open.fda.gov/license/

LMA North America Inc / initiated 2012-05-23 / Terminated / root cause: manufacturing process

FDA source

LMA North America Inc began a recall of LMA Esophageal Intubation Detector (EID), Catalog Number EID100 The device is used to assist verification of placement of the endotracheal tube or... on 2012-05-23. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2022-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-23
Posted: 2012-07-17
Terminated: 2012-12-26
Recalling firm: LMA North America Inc
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
Product code: BTR Tube, Tracheal (W/Wo Connector)
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: LMA North America Inc. sent a recall letter dated May 23, 2012, for US customers, and May 24, 2012, for International customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to fill out the bottom portion of the recall letter and promptly fax it back to LMA North America at (858) 622-4130. If customers have units of EID100 from the affected lots remaining in stock, customers were instructed to arrange for immediate return by contacting LMANA's customer service department at (800) 788-7999, menu selection #2. For further questions please contact Customer Service Representative at (800) 788-7999.
Quantity in commerce: 18,799 units
Distribution: Worldwide Distribution--USA (nationwide) and the countries of Canada, United Kingdom, ZA, and Australia.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2022-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2022-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-25	2012-07-17

Product code BTR

K930741Class IIEsophageal Intubation DetectorWolfe-Carney Medical / cleared 1993-08-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)