FDA WARNING_LETTER - Fresenius Medical Care Holdings, Inc

The FDA issued a Warning Letter to Fresenius Medical Care Holdings, Inc. concerning their modified CombiSet True Flow Series Hemodialysis Blood Tubing Sets (Part Numbers 03-2695-9 and 03-2795-7) marketed in the U.S. The firm had implemented design changes, specifically altering a tubing segment's wall thickness and hardness. While an original 510(k) (K962081) was cleared for the Combilines Hemodialysis Blood Tubing Set, the FDA determined that these specific modifications were not cleared under that submission. Despite the firm's claims that design validations raised no new issues, the change in material hardness demonstrably affected device performance, leading to device failures and a subsequent recall initiated on November 19, 2010. Consequently, the FDA found the modified devices to be adulterated under section 501(f)(1)(B) of the Act (21 U.S.C. 351(f)(1)(B)) due to the lack of an approved Premarket Approval (PMA) or Investigational Device Exemption (IDE) application. Furthermore, the devices were deemed misbranded under section 502(o) of the Act (21 U.S.C. 352(o)) because the firm failed to notify the agency of its intent to introduce these modified devices into commercial distribution, as required by section 510(k) (21 U.S.C. 360(k)). The letter mandates prompt corrective action, requiring a written response within fifteen working days detailing specific steps, prevention plans, documentation, and a timetable. Failure to comply could lead to regulatory actions such as seizure, injunction, civil money penalties, and impact on federal contracts.