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
Alcon canada is conducting this voluntary medical device removal for specific lots of centurion fms packs due to the possible presence of a molding irregularity found within the aspiration leur which may result in a reduction of vacuum within the aspiration line.
Model Catalog: 8065752918 (Lot serial: 1802311H); Model Catalog: 8065752917 (Lot serial: 1802311H); Model Catalog: 8065752201 (Lot serial: 1804698H); Model Catalog: 8065752200 (Lot serial: 1804698H); Model Catalog: 8065752201 (Lot serial: 1804697H); Model Catalog: 8065752200 (Lot serial: 1804697H); Model Catalog: 8065752201 (Lot serial: 1804696H); Model Catalog: 8065752200 (Lot serial: 1804696H); Model Catalog: 8065752201 (Lot serial: 1804691H); Model Catalog: 8065752200 (Lot serial: 1804691H); Model Catalog: 8065752201 (Lot serial: 1794168H); Model Catalog: 8065752200 (Lot serial: 1804849H); Model Catalog: 8065752201 (Lot serial: 1794164H); Model Catalog: 8065752200 (Lot serial: 1794164H); Model Catalog: 8065752201 (Lot serial: 1794163H); Model Catalog: 8065752200 (Lot serial: 1794163H); Model Catalog: 8065752201 (Lot serial: 1794161H); Model Catalog: 8065752200 (Lot serial: 1794161H); Model Catalog: 8065752201 (Lot serial: 1794159H); Model Catalog: 8065752200 (Lot serial: 1794159H); Model Catalog: 80657522
제품 설명
CENTURION VISION SYSTEM - ACTIVE IRRIGATION FMS PACK INFUSION SLEEVES;CENTURION VISION SYSTEM - ACTIVE IRRIGATION FMS PACK W/INTREPID ULTRA SLEEVES;CENTURION VISION SYSTEM - ACTIVE IRRIGATION FMS PACK BASIC