Health Canada — Medical Devices · Canada · 2017-01-06 · Type II
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Reported risk: Macopharma was informed of a number of fast filtrations on the NPT6280LA reference in use in France. This has caused an absence of effective filtration through the media of the LCRD2 Filters. This sporadic defect is linked to a partial absence of the weld in the media caused by poor positioning (fold or gap) of the last polyester layer in the mattress.
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