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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The hand piece's outer hose can rupture without warning if occluded by being stepped on setting equipment on pinching kinking clamping or any other method of occluding hand piece hose during use.
Model Catalog: BLACKMAX-N (Lot serial: ALL LOTS BEFORE MAY 2009); Model Catalog: BLACKMAX-O (Lot serial: ALL LOTS BEFORE MAY 2009); Model Catalog: MICROMAX (Lot serial: ALL LOTS BEFORE MAY 2009); Model Catalog: BLACKMAX-N-LP (Lot serial: ALL LOTS BEFORE MAY 2009); Model Catalog: XMAX (Lot serial: ALL LOTS BEFORE MAY 2009); Model Catalog: XMAX-H (Lot serial: ALL LOTS BEFORE MAY 2009)