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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Cardinal health has been informed by medtronic of a medical device correction in regards to covidien devon light gloves contained in presource kits. this correction has been initiated to update labeling of the instructions for use. medtronic advises that on rare occasion the devon light glove may split upon application to the devon light handle adapter. a split in the glove can potentially lead to a breach in the sterile barrier between the glove and the handle adapter. the following statement will be added to the instructions for use to help or staff ensures that the sterile field is maintained "after application inspect the light glove for barrier integrity".