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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Instrument can experience a spontaneous dialysate proportioning ratio change which can result in severe patient acid-base disturbances.
Model Catalog: K100CIT (Lot serial: ALL SERIAL NUMBERS); Model Catalog: K100S05 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: N1000DP (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SYS1000 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SYS1000-3S (Lot serial: ALL SERIAL NUMBERS); Model Catalog: N100HCT (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SYS1000-L3PHA (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SYS1000-L3PDP (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SYS1000-L3PA (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SYS1000-L3P (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SYS1000-L3DPHA (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SYS1000-L3DPA (Lot serial: ALL SERIAL NUMBERS); Model Catalog: STS1000-L3PDP (Lot serial: ALL SERIAL NUMBERS)