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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There is a manufacturing quality issue with the t-piece circuits for the panda and giraffe resuscitation system integrated into the infant radiant warmers. this issue occurs when then t-piece resuscitationcircuit is not able to achieve maximum pip (peak inspiratory pressure) of 45+/-5 cmh2o as measured by the built-in airway pressure manometer during the pre-use checkout procedure.
Model Catalog: GIRAFFE WARMER (Lot serial: M1091316); Model Catalog: GIRAFFE WARMER (Lot serial: M1091335); Model Catalog: GIRAFFE WARMER (Lot serial: M1091365); Model Catalog: PANDA WARMER (Lot serial: M1091365); Model Catalog: PANDA WARMER (Lot serial: M1091316); Model Catalog: PANDA WARMER (Lot serial: M1091335)