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 distal end of the tube may be printed incorrectly, with catalog numbers v5-16037 and 5-16037 stating 'bronchial - right' instead of 'bronchial - left', and catalog number 5-16137 stating 'bronchial - left' instead of 'bronchial - right'.
조치
Customers were notified via Federal Express, Next Business Day Delivery, on February 23, 2005. The accounts were informed of the mislabeling and were instructed to inspect the product lots for any incorrectly printed devices, comparing the writing on the sleeve of the blue bronchial tube with the package label which is correct, and to return all identified affected product to Teleflex Medical, Hudson RCI.
Nationwide and internationally to Argentina, Canada, Chile, China, Costa Rica, Hong Kong, Korea, the Netherlands, South Africa and Vietnam.
제품 설명
Sheridan Sher-I-Bronch Endobronchial Tube for Right Bronchial Intubation; an Rx, sterile, sinlge use endobronchial tube with modified tip for right bronchial intubation, 37 Fr.; Hudson Respiratory Care Inc., Temecula, CA 92589-9020, Manufactured in Mexico; catalog number (REF) 5-16137