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 infusors may leak and not apply the desired pressure to the i.V. solution bag and subsequently the rate of infusion may be inadequate. if used in conjunction with an arterial pressure line for the purpose of measuring blood pressure a potential falsely low blood pressure reading may result. this issue may impact patient safety.
Model Catalog: IN900012 (Lot serial: For 2010 - Lot 0010 - 3350); Model Catalog: IN900012 (Lot serial: For 2009 - Lot 2449 - 3659); Model Catalog: IN950012 (Lot serial: For 2010 - Lot 0010 - 3350); Model Catalog: IN800012 (Lot serial: For 2009 - Lot 2449 - 3659); Model Catalog: IN800012 (Lot serial: For 2010 - Lot 0010 - 3350); Model Catalog: IN950012 (Lot serial: For 2009 - Lot 2449 - 3659)