Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
데이터 추가 비고
원인
The pilot tube disconnects from the pressure monitor due to inappropriate adhesive type/procedure.
조치
Customers are being requested to isolate and return any affected stock.