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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This recall has been intiated because ethicon has revised its directions for convenience kit manufactures such that these products can no longer be placed in kits that will undergo ethylene oxide sterilization. the revision in direction is based on a chage in the product packaging. the ethicon sturues contained in the affected packs have undergone re-steriliation with ethylene oxide potentially causing a recution in tensile strength.