Product: DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Medical Care NA Waltham, MA 02451, NDC 49230-206-62.
Reason for recall: Lack of Sterility Assurance
Recall initiated: 20231228
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated