Health Canada — Medical Devices · Canada · 2021-02-05 · Type II
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Reported risk: Maquet Cardiopulmonary GmbH became aware of a missing cable tie in the cardioplegia (Plegiox) line to secure the connection between connector and tubing next to the roller pump for the article numbers subject of this FSN. A missing cable tie could lead to a leakage and/or loosening of the tube in the cardioplegia (Plegiox) line.
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