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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An internal finding identified the presence of pinholes/cuts in some of the tyvek pouches of the vacuum tubing sets included as an accessory to these products. as a result there is a potential for the pouch integrity to be compromised which may result in compromised sterility of the product. if the compromised product is used in surgery there is a potential risk of infection for the patient.