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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These packs contain laparotomy sponges that have been recalled by medtronic (covidien curity curity x-ray kerlix x-ray vistec x-ray). medtronic states that the seal integrity of the lap sponge package may be compromised resulting in potential breach of the sterile barrier. this could lead to an increased risk of infection. medtronic reports no adverse incidents associated with this issue. medline canada has not received any complaints of this nature.