International safety notice

As a result of investigating defect reports received from the market at overseas manufacturers, we found that the venous blood reservoir of this product has It was discovered that there was a possibility that there was a foreign substance mixed in. After investigating the cause of this event, we found that the mixed foreign matter was connected to the device used for product leak testing and the main venous blood collection. It turned out to be a piece of gasket used in the connection jig (quick connector) to the tank. After investigating the cause of the occurrence, we found that the gasket diameter of the quick connector used before June 21, 2023 was It is narrow compared to the port diameter on the pulse blood reservoir side, and depending on the condition of the gasket and the connection, the gasket pieces generated due to friction may be There was a risk of it falling into the venous blood reservoir. In response to the results of this investigation, overseas manufacturers will implement a voluntary circular for products manufactured before June 21, 2023 and within the expiration date. We have started taking measures.

Japan / PMDA Recalls · JPN · Jul 29, 2024