Institute of Good Manufacturing Practices India®

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Fresenius Medical Care recalls 2M dialysis devices due to toxin exposure risk

In 2022, the FDA alerted healthcare providers to potential toxin exposure from Fresenius Medical Care hemodialysis systems, involving non-dioxin-like (NDL) polychlorinated biphenyl acid (PCBA) and NDL polychlorinated biphenyls (PCBs) due to silicone tube manufacturing processes.

Fresenius Medical Care responded by switching to platinum catalyst silicone tubing and recalling devices produced with the previous method. Subsequently, they discovered potential NDL-PCBA leaching from Stay-Safe Catheter Extension Sets and Stay-Safe/Luer Lock Adapters, prompting another recall.

Exposure to NDL-PCBs or related compounds can lead to health issues like liver problems and neurobehavioral changes. Fresenius Medical Care initiated a recall in January for nearly 2.2 million devices, particularly targeting patients under 40kg at risk of excessive NDL-PCBA exposure, distributed in the U.S. between 2003 and 2024, with no reported injuries or deaths.

The company advised healthcare professionals to use the shortest extension set for lighter patients and to avoid the adapter when possible, providing details on NDL-PCBA exposure levels. The FDA also reported a recall by Outset Medical for Tablo hemodialysis devices due to potential NDL-PCBA leaching within the first 336 hours of use, suggesting tubing replacement for machines under 336 hours of use and considering alternative devices until serviced.