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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These packs contain a light handle cover manufactured by medtronic (formerly covidien). the covidien devont light handle cover is a sterile plastic sheath that slides over the handle of the overhead surgical light. it allows a gloved surgeon or or nurse to grab the handle with sterile gloves to maintain sterility. medtronic has initiated a voluntary recall of the light handle cover due to potential defects that may compromise the integrity of the product. a copy of medtronic's recall letter is attached.