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.
데이터 추가 비고
원인
The manufacturer has become aware of an increase in the number of complaints for enterlite infinity enteral pump delivery sets with enfit connector system and transitional stepped connectors (administration sets) that are used with the enteralite infinity enteral feeding pump. customers are reporting formula leaking between the purple enfit connector and the white transitional stepped connector due to cracking or breaking of the purple connector.