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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New more stringent internal testing conducted by maquet cardiopulmonary to reduce the possibility of any quality issues in the field has indicated that specific oxygenator lots may not meet product specifications. specifically internal testing indicates that the outlet or/and inlet connector port of the unit may dislodge and separate from the main body of the oxygenator. please note that this recall pertains to specific lots of oxygenators. users need to continue to use the reusable mechanical clamp provided by maquet with all remaining maquet quadrox oxygenators currently in distribution. the specific lots within this recall may have an increased tendency for separation as indicated in the internal testing results.