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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원인
Manufacturer has determined that condensation in the drain line tubing may lead to a false blood detection alarm activating when no blood is present. also liquid spills such as saline can create bridges of resistance between the circuit components causing the circuit not to function as intended. this can impact initiation or continuation of therapy.
Model Catalog: 0998-00-0446-XX (Lot serial: S806023-D2); Model Catalog: 0998-00-0446-XX (Lot serial: S803570-B0); Model Catalog: 0998-00-0446-XX (Lot serial: S803551-B0); Model Catalog: 0998-00-0446-XX (Lot serial: S803492-B0); Model Catalog: 0998-00-0446-XX (Lot serial: S803634-C0); Model Catalog: 0998-00-0446-XX (Lot serial: S804566-L0); Model Catalog: 0998-00-0446-XX (Lot serial: S81995-A9); Model Catalog: 0998-00-0446-XX (Lot serial: S803567-B0); Model Catalog: 0998-00-3013-XX (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 0998-00-0446-XX (Lot serial: S803785-E0); Model Catalog: 0998-00-0446-XX (Lot serial: S803639-C0); Model Catalog: 0998-00-0479-XX (Lot serial: S806816-A3); Model Catalog: 0998-00-0479-XX (Lot serial: S806811-A3); Model Catalog: 0998-00-0479-XX (Lot serial: S805908-B2); Model Catalog: 0998-00-0479-XX (Lot serial: S805907-B2); Model Catalog: 0998-00-0479-XX (Lot serial: S81212-H8); Model Catalog: 0998-00-0479-XX (Lot serial: S804785-B1); Model Catalog: 0998-00-3023-53 (Lot serial:
제품 설명
SYSTEM 98 (IABP) INTRA-AORTIC BALLOON PUMP;CS100 INTRA AORTIC BALLOON PUMP;SYSTEM 98XT INTRA AORTIC BALLOON PUMP;CS300 INTRA AORTIC BALLOON PUMP SYSTEM - MAIN UNIT