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
Physio-control's supplier of quik-combo adult pacing/defibrillation/ecg electrodes with edge system technology and redi-pak preconnect system is voluntarily recalling specific production lots. the defibrillation electrodes are used in conjunction with certain physio-control lifepak products. this voluntary recall is being conducted due to a low-level potential for damage to the wire insulation during the manufacturing process of the affected lots. the use of products with this condition may result in a potentially increased risk for reduced or no patient therapy arcing of current sparking and patient and/or clinician burns.
Model Catalog: 3202674-XXX (Lot serial: 516907); Model Catalog: 3202674-XXX (Lot serial: 519815); Model Catalog: 3202674-XXX (Lot serial: 519816)
제품 설명
PHYSIO-CONTROL QUIK-COMBO PACING/DEFIBRILLATION/ECG ELECTRODES WITH EDGE SYSTEM TECHNOLOGY AND REDI-PAK PRECONNECT SYSTEM;Quik-Combo pacing/defibrillation/ECG electordes with EDGE System technology and REDI-PAK preconnect system