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 9025tru abg kits(s) have been identified as missing the locking clasp component. carefusion/bd has identified a potential customer/user safety risk associated with the missing locking clasp component. the potential user/clinician safety risk associated with the missing locking clasp component is exposure to a contaminated needle. at worst case this could result in an infection specifically cross-contamination due to a significant exposure to blood borne pathogens.