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.

Recall Number: D-0218-2024

Firm: Fresenius Medical Care Holdings, Inc.

Classification: Class II

Status: Ongoing

Report Date: 20240110

Initiation Date: 20231228

Termination Date:

Lack of Sterility Assurance

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.