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U.S. Department of Health and Human Services

Class 2 Device Recall LMA

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  Class 2 Device Recall LMA see related information
Date Initiated by Firm January 13, 2015
Date Posted February 10, 2015
Recall Status1 Terminated 3 on September 27, 2016
Recall Number Z-1085-2015
Recall Event ID 70258
Product Classification Airway, oropharyngeal, anesthesiology - Product Code CAE
Product LMA (Laryngeal Mask Airway) Supreme (New Cuff) Size 5, Sterile, Single use,

Product Usage: Achieve and maintain control of airway during routine anaesthesia in fasted patient using either spontaneous or positive pressure ventilation, cardiopulmonary resuscitation, the failed intubation situation and the cannot-intubate-cannot-ventilate situation.
Code Information Catalog No(s): 175050, Lot no. HMAUGK
Recalling Firm/
Manufacturer
Teleflex Medical
2917 Weck Dr
Research Triangle Park NC 27709-0186
For Additional Information Contact Tara Torres
610-378-0131
Manufacturer Reason
for Recall
The labelling of units from the affected lot indicates that it contains a size 5 LMA Supreme (New Cuff), but may contain a size 4 LMA Supreme (New Cuff).
FDA Determined
Cause 2
Other
Action Teleflex sent an Urgent Medical Device Recall Notification letter dated January 13, 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately discontinue use and quarantine any products and to return it to Teleflex Medical. Customers were asked to complete the enclosed Recall Acknowledgement Form via fax even if they do not have the affected product in stock. For questions contact your local sales representative or Customer Service at 1-866-246-6990.
Quantity in Commerce 2640 units
Distribution Worldwide Distribution - U.S Nationwide in the states of: AZ, CA, DE, FL, GA, IL, KY, MO, NY, OK, PA, TX, VA & WA and the country of Canada.
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.
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