Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
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On april 4 2014 a communication from the osta us distributor drew attention to the fact that part 000878-4 falope-ring dilator was inadvertently made available through the order system to customers and osta was shipping this item to our distributors in a non-sterile state. this item is normally only intended for use as a component provided with the falope ring band frb- 30 kits. the frb-30 kits including this component are sold sterile. this item is a dilator intended to assist placement of the falope band on the applicator. it contacts the sterile falope ring band as the band is loaded onto a reusable applicator and just prior to the band's implantation in the patient. as such it must be sterile in order to avoid the possibility of contaminating the falope ring band prior to use. no complaints related to these items have been received.