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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Armstrong medical ltd is investigating the heater wire retainer (located in the heated limbs of adult corrugated heated ventilator and cpap breathing circuits as a means to locate the heater wire in a fixed position). the retainer is white or off-white in color and made from polymeric (plastics) material. if breakage of this component were to occur there could be a possible inhalation risk to the patient.
Model Catalog: AMCP1409/004 (Lot serial: 080310 TO 310812); Model Catalog: AMCPSI01052 (Lot serial: 080310 TO 310812); Model Catalog: AMCPUK01103 (Lot serial: 080310 TO 310812); Model Catalog: AMVC1792/130 (Lot serial: 080310 TO 310812); Model Catalog: AMVC1774/101 (Lot serial: 080310 TO 310812); Model Catalog: AMVC1774/102 (Lot serial: 080310 TO 310812); Model Catalog: AMVC1774/105 (Lot serial: 080310 TO 310812); Model Catalog: AMVC1774/106 (Lot serial: 080310 TO 310812); Model Catalog: AMVC1775/101 (Lot serial: 080310 TO 310812); Model Catalog: AMVC1775/102 (Lot serial: 080310 TO 310812); Model Catalog: AMVC1775/106 (Lot serial: 080310 TO 310812); Model Catalog: AMVC1775/108 (Lot serial: 080310 TO 310812); Model Catalog: AMCPUK01109 (Lot serial: 080310 TO 310812); Model Catalog: AMCP1409/003 (Lot serial: 080310 TO 310812)