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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Complaints have been received of some devices exhibiting inaccurate flow rates and leakage. if the device is unable to regulate flow as set and confirmed by the attending medical staff and the delivery of essential medications or treatment is dependent on the device's function this may result in possible injury to the patient.
Model Catalog: P-S2V-60 N (Lot serial: 0603241-1006094); Model Catalog: P-S2V-60 (Lot serial: 0603241-0811031); Model Catalog: P-S2V-60 N (Lot serial: 0603241-0811031); Model Catalog: P-S2V-60 (Lot serial: 0603241-1006094); Model Catalog: P-S2-12 (Lot serial: 0603241-1101064); Model Catalog: P-S2-12 (Lot serial: 0603241-1103114); Model Catalog: P-S2-12 N (Lot serial: 0603241-1103114); Model Catalog: P-S2-12 N (Lot serial: 0603241-1101064)