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U.S. Department of Health and Human Services

Class 2 Device Recall LMA Esophageal Intubation Detector (EID), Catalog Number EID100

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 Class 2 Device Recall LMA Esophageal Intubation Detector (EID), Catalog Number EID100see related information
Date Initiated by FirmMay 23, 2012
Date PostedJuly 17, 2012
Recall Status1 Terminated 3 on December 26, 2012
Recall NumberZ-2022-2012
Recall Event ID 62337
510(K)NumberK930741 
Product Classification Tube, tracheal (w/wo connector) - Product Code BTR
ProductLMA 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
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.
FEI Number 3001338204
Recalling Firm/
Manufacturer		 LMA North America Inc
4660 La Jolla Village Dr Ste 900
San Diego CA 92122-4608
For Additional Information Contact
858-587-4025
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionLMA 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 Commerce18,799 units
DistributionWorldwide Distribution--USA (nationwide) and the countries of Canada, United Kingdom, ZA, and Australia.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = BTR
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