Stay-Safe dialysis accessories from Fresenius Medical Care. Stay-Safe catheter extension sets and Stay-Safe/Luer Lock adapters, which are used to connect peritoneal dialysis catheters to peritoneal dialysis systems, are being recalled as part of a larger FDA action on potentially toxic compounds in Fresenius Kabi AG dialysis machines. Patients who weigh less than 50 kg (about 90 lb) may be exposed to high levels of non-dioxin-like polychlorinated biphenyl acids (NDL-PCBAs) during treatment with the equipment. Potential long-term consequences of NDL-PCBA overexposure may include endocrine dysfunction, liver issues, neurobehavioral changes, skin problems (acne, rashes), and male infertility. The recall, which has not been linked to any adverse events, includes more than 2 million devices distributed between March 2023 and January 2024.

Recalls Round-Up: Class 1s For BioMérieux, Fresenius, Draeger, More

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