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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In previous recall (hc# 55250) this addressed the flexible applicator probes that can shrink by up to 2mm after autoclaving. it has been determined that a portion of the shipped inventory of flexible applicator probes was not heat annealed. this recall supplements previous instructions by requring users to stop using any flexible applicator probes that may still be in inventory with lot numbers d01 to h14 inclusive. these applicator probes are to be returned to varian brachytherapy for replacement with lots after h14.