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.
데이터 추가 비고
원인
Baxter is notifying customers of a potential issue with the occluder assembly for specific serial numbers of homechoice pro devices. the occluder may contain sharp edges and/or may separate from the back plate which may cause the occluder assembly to fail resulting in an unrecoverable slow flow/no flow alarm or an unrecoverable system error. the device will fail in a safe position and prevent solution from being delivered to the patient but patient will also not be able to perform/complete therapy.