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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The tether attaching to the double swivel cap may partially or completely break at the attachent points. the brojen tether may lodge inside the dual swivel tubing or body during shipment to the end user resulting in the potential for the accidental aspiration of the tether into the patient's lungs.