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 certain packages the seal between the white polyethylene and the clear plastic may be missing on the hand controller sheath package resulting in a potential breach of the sterility of this accessory.
Model Catalog: AVA 500 HCS (Lot serial: distributed from March 2008); Model Catalog: AVA 500 HCS (Lot serial: > 100 lot numbers); Model Catalog: AVA 500 HCS (Lot serial: contact Manufacturer)