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: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
원인
A review of manufacturing records has revealed that some control pumps produced at ams were released despite not meeting all final product release criteria.