Affected devices can only be identified by comparing product code and manufacture date stated on the packaging to the product list in the manufacturer’s FSN. The breach in the packaging is not visible.In addition to the FSN, which details the affected products, please refer to the spreadsheet which accompanies this MDA for additional unique device identification information and national supply chain codes (where available).
Note published by the authorities from the Netherlands: This message is a warning from the manufacturer. After placing a medical device on the market, the manufacturer is obliged to follow the device and, where necessary, to improve it. When there is a risk for the user, the manufacturer must take action. The manufacturer informs users and the inspection of this action with a warning (Field Safety Notice). See also medical device warnings. This is part of the supervision of medical technology.