Z-0518-2019 Class III Terminated

Recalled by Fresenius Medical Care Renal Therapies Group, LLC — Waltham, MA

FDA device recall Z-0518-2019 was initiated by Fresenius Medical Care Renal Therapies Group, LLC on October 9, 2018 and is designated Class III. Reason for recall: Discolored powder has confirmed the presence of a foreign substance The recall status is terminated (terminated August 5, 2021). Affected quantity: 22320.