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: Technisonic Systems 2013 Ltd, 2B Target Court, Wairau Valley, Glenfield, Auckland 6027
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Manufacturer recalling product with expiration dates prior to april 2017 because the tyvek plastic seal may be missing on the hand controller sheath package resulting in a potential.