Z-2022-2012 Class II Terminated
FDA device recall Z-2022-2012 was initiated by LMA North America Inc on May 23, 2012 and is designated Class II. 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 … The recall status is terminated (terminated December 26, 2012). Affected quantity: 18,799 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 25, 2012
- Initiation Date
- May 23, 2012
- Termination Date
- December 26, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18,799 units
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
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.
Distribution Pattern
Worldwide Distribution--USA (nationwide) and the countries of Canada, United Kingdom, ZA, and Australia.
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.