Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
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Recalling Organisation: InterMed Medical Ltd, 71 Apollo Drive, Albany, AUCKLAND 1311
원인
The manufacturer advised that they have become aware that defects (bulging, gaps, etc) are found in some of the connectors on the dressing in the prevena incision management kit.