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.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
데이터 추가 비고
원인
Hospira has received customer reports of the plum a+ infusion pumps with no audible alarm conditions which have been associated with failure of the piezoelectric assembly due to component quality issues.
Model Catalog: 20679 (Lot serial: All serial #); Model Catalog: 20678 (Lot serial: All Serial #); Model Catalog: 12618 (Lot serial: All Serial #); Model Catalog: 20792 (Lot serial: All serial #); Model Catalog: 12391 (Lot serial: All serial #)