Class II Recall

Fresenius Medical Care Holdings, Inc.

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
Lack of Sterility Assurance
Classification
Class II
Status
Ongoing
Lot
Part Number: 077-60621, Lot #: 23JK02010, Exp. Date 1/31/2025
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.