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
Nebulizer - Product Code CAF
원인
Decreased in flow output; through the nebulizer -(when used at higher oxygen concentration settings, this decrease in flow, may lower the oxygen concentration inspired by the patient).
조치
Customers were notified by an Urgent Medical Device Recall letter on/about 08/22/2007. They were instructed to return the affected products to Teleflex Medical or acknowledge that the products no longer exist. In addition, each were instructed to forward the letter if they have further distributed into institutional settings or to homecare patients and retrieve relevant product from those locations. This recall is to the consumer/user level via sub-recall from distributors or direct accounts as per the Recalling firm.
Worldwide: USA, Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, France, Germany, Guatemala, India, Mexico, Panama, Peru, Philippines, South Korea, Thailand, United Arab Emirates, and The United Kingdom.
제품 설명
HUDSON RCI¿, Variable Concentration, Large Volume Nebulizer, Catalog Number (REF) 1770 and 41770, Rx Only, Teleflex Medical, Research Triangle Park, NC 27709.