FDA Warning Letter Sent To Fresenius Medical (FMS)

The Food and Drug Administration (FDA) has learned that your firm is marketing the Fresenius Medical Care FMS North America CombiSet True Flow Series Hemodialysis Blood Tubing Set With Priming Set and Transducer Protectors, Part Numbers 03-2695-9 and 03-2795-7 (modified CombiSet) in the United States (U.S.). Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body. More information can be found here.