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.
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Manufacturer has found the potential for fluid or air to be passedthrough the venous line clamp that could cause an air emboli condition when the tubing is not centered in the clamp.
Model Catalog: ARENASPX-H (Lot serial: ALL SERIAL NUMBERS); Model Catalog: ARENASPX-BDH (Lot serial: ALL SERIAL NUMBERS); Model Catalog: ARENASPX-BDO (Lot serial: ALL SERIAL NUMBERS); Model Catalog: ARENASPP-DH (Lot serial: ALL SERIAL NUMBERS); Model Catalog: ARENA SPP (Lot serial: ALL SERIAL NUMBERS); Model Catalog: ARENASPP-D (Lot serial: ALL SERIAL NUMBERS)