U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
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).
조치
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.
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.
제품 설명
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.