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 purpose of this notice is to inform users of the potential for blockage within the shaft of the applicator tip which may render the tip unusable. this blockage has occured in a limited number of cases.
Model Catalog: BG3010-5-G-RT (Lot serial: ALL LOTS); Model Catalog: BGAT-RT (Lot serial: ALL LOTS); Model Catalog: BG3010-5-G-RT (Lot serial: 7RT002); Model Catalog: BGAT-RT (Lot serial: 7RT002); Model Catalog: BG3010-5-G-RT (Lot serial: 7RT001); Model Catalog: BGAT-RT (Lot serial: 7RT001)