Class II

Drug Recall: 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.

Fresenius Medical Care Holdings, Inc. · December 28, 2023

Reason for Recall

Lack of Sterility Assurance

Distribution

Nationwide within the United States

States Affected

NATIONWIDE

Quantity Affected

69,590 bags

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0218-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.