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The quality issue under investigation is applicable to the "connection cable venous probe, l0.23m". The part causing the nonconformance under investigation is responsible for data transmission between the Cardiohelp-i and the venous probe. A noticeable high number of breaks in the insulation sheath and a shielding breach of the venous probe connection cable was observed.
Recall Start Date: November 21, 2023
Maquet Cardiopulmonary Gmbh
Kehler Strasse 31, Rastatt, Germany, 76437