Recall Z-2022-2012— LMA North America Inc
Class II · Terminated
Class II FDA medical device recall by LMA North America Inc, initiated 2012-05-23, terminated 2012-12-26. It names one FDA 510(k) clearance: K930741. 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. Reason: 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..
- Recalling firm
- LMA North America Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-05-23
- Terminated
- 2012-12-26
- Firm location
- San Diego, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.