The FDA has issued a warning to dialysis giant Fresenius following a prolonged investigation into potentially harmful chemicals in its hemodialysis machines. The warning letter, posted in December, criticized Fresenius for its slow response to the issue, citing a lack of corrective action for almost two years after learning of the problem. The FDA raised concerns about Fresenius’ failure to adequately investigate the health impact of polychlorinated biphenyl (PCB) compounds leaching from the machines’ silicone tubing. The company’s recall of affected machines, issued in October 2023, comes nearly three years after first being alerted to the problem. The FDA highlighted serious health consequences associated with the use of affected machines. Fresenius is now under scrutiny for its handling of the situation and faces the challenge of addressing the FDA’s concerns.
January 24, 2024