Fresenius Medical Care Holdings, Inc. recalls DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Med
Recalled January 10, 2024 · FDA recall D-0218-2024 · Fresenius Medical Care Holdings
Hazard
Lack of Sterility Assurance · FDA Class II
Units
69,590 bags
Sold at
Nationwide within the United States
Description
Lack of Sterility Assurance
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.
Manufacturer(s)
Fresenius Medical Care Holdings, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →