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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We have identified that the reprocessing instructions may not provide sufficiently detailed information for the cleaning disinfection and sterilization of these products. our preliminary investigation indicates that validation data related to the reprocessing of these devices may not meet current standards. there have been no reports of adverse reactions related to inadequate cleaning disinfection or sterilization associated with these devices.
Model Catalog: J-PLC-751810 (Lot serial: all lots); Model Catalog: 090100 (Lot serial: all lots); Model Catalog: J-EIE-051500 (Lot serial: all lots); Model Catalog: J-CRKP-042900 (Lot serial: all lots); Model Catalog: J-RSN-901600 (Lot serial: all lots); Model Catalog: 095015 (Lot serial: all lots); Model Catalog: 095000 (Lot serial: all lots); Model Catalog: 095030 (Lot serial: all lots)