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U.S. Department of Health and Human Services

Class 2 Device Recall LMA Unique

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  Class 2 Device Recall LMA Unique see related information
Date Initiated by Firm June 18, 2003
Date Posted July 29, 2003
Recall Status1 Terminated 3 on November 03, 2003
Recall Number Z-1053-03
Recall Event ID 26577
Product Classification Airway, Oropharyngeal, Anesthesiology - Product Code CAE
Product LMA- Unique

Laryngeal Mask Airway

Size 4, Catalog No. 12140, Lot FH041202
Size 4, Catalog No. 12150, Lot FJ021202
Code Information Lots FH041202 and FJ021202
Recalling Firm/
LMA North America Inc
9360 Towne Centre Dr
San Diego CA 921213030
For Additional Information Contact Ms. Cindy Luchetti
Manufacturer Reason
for Recall
Sterility cannot be assured
FDA Determined
Cause 2
Action Recall letters were issued on June 18, 2003 to customers. It requests return of product and included a request to fax back inventory description.
Quantity in Commerce 2,579
Distribution Nationwide
Total Product Life Cycle TPLC 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.