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.
데이터 추가 비고
원인
Manufacturer has received reports of air bubbles in the tubing sets past the air detectorwithout an alarm alerting the operator of potential air in the tubing. potentially could cause air embolisms.
Model Catalog: 5M5551 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 5M5538 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: ARENASPP-D (Lot serial: ALL SERIAL NUMBERS); Model Catalog: ARENA SPP (Lot serial: ALL SERIAL NUMBERS); Model Catalog: ARENASPP-DH (Lot serial: ALL SERIAL NUMBERS); Model Catalog: ARENASPP-H (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SYS1000-L3PA (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SYS1000-L3P (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SYS1000-L3DPHA (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SYS1000GIA (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SYS1000-L3PHDP (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SYS1000-L3PHA (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SYS1000-L3PDP (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SYS1000-L3PH (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SYS1000-L3DPA (Lot serial: ALL SERIAL NUMBERS); Model Catalog: ARENASPX-O (Lot serial: ALL SERIAL NUMBERS); Model Catalog: ARENA SPX (Lot serial: ALL SERIAL