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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Positive results(non-sterile) units found during routineannual re-validation of the ethylene oxide sterilization cycle at an outside subcontractor.
Model Catalog: SLHA 033 SS (Lot serial: F2KN69893); Model Catalog: SLHA 033 SS (Lot serial: F2MN78131); Model Catalog: SLHA 033 SS (Lot serial: R3HN89113); Model Catalog: SLGS 033 SS (Lot serial: F2PN86704); Model Catalog: SLGS M33 SS (Lot serial: R3HN06269); Model Catalog: SLGS M33 SS (Lot serial: F2PN86704); Model Catalog: SLGS 033 SS (Lot serial: F2KN78263); Model Catalog: SLGS M33 SS (Lot serial: F2KN78263); Model Catalog: SLGS 033 SS (Lot serial: R3JN94940); Model Catalog: SLGS M33 SS (Lot serial: R3JN94940); Model Catalog: SLGS 033 SS (Lot serial: F2MN78131); Model Catalog: SLGS M33 SS (Lot serial: F2MN78131); Model Catalog: SLGS 033 SS (Lot serial: R3HN06269); Model Catalog: SLGS M33 SS (Lot serial: R3AN96873); Model Catalog: SLGS 033 SS (Lot serial: R3AN96873); Model Catalog: SLGS M33 SS (Lot serial: R3JN94938); Model Catalog: SLGS 033 SS (Lot serial: R3JN94938)