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.
데이터 추가 비고
Tube tracheostomy and tube cuff - Product Code JOH
원인
The connector may disconnect from the tracheostomy tube during use.
조치
Teleflex sent an Urgent Field Safety Notice dated August 26, 2016, to all affected consignees. The letter requested that consignees cease use and distribution of stock, quarantine immediately, and return the product. Also, the letter requested a sub-recall if the product had been further distributed. The letter included an Acknowledgement Form which is to be returned. Customers with questions were instructed to contact their local sales representative or Customer Service.
For questions regarding this recall call 610-378-0131.
Worldwide Distribution: US (nationwide) to CA and countries of: Austria, Belgium, France, Germany, Italy, Japan, Poland, and Turkey.
제품 설명
Willy Rusch GmbH Tracheostomy Tube Set || Cannulation of tracheotomised patients, particularly in the case of a narrow tracheostoma and narrow-lumen tracheas. When using cannulas with curr. For short term intermittent inflation.