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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Baxter has identified an issue with the large clamp that is used to close the drain tube on the 15l cycler drainage bag. the large clamp may not fully close the drain tube and may result in leakage. if leakage occurs there is a potential risk of contamination or infection to a patient/caregiver and a possibility of a slipping hazard if there is a fluid spill. there have been no injuries reported for this issue.