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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Cardinal health has become aware of a potential breach of sterility in the packaging of certain jackson-pratt perforated and hemaduct wound drainage systems. in a small percentage of product (approximately 1.6%) the inner packaging (polybag) is caught in the seal area of the outer tyvek pouch potentially compromising the sterility of the package contents. while sterility is only impacted if the polybag fully breaches the seal (approximately 0.23% of product) as a precautionary measure cardinal health is taking this action to ensure that product is not used if any portion of the polybag is caught in the seal area. use of impacted products could result in an increased risk of infection.