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.

FDA recall notice · announced January 10, 2024 · Fresenius Medical Care

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Notes

Distribution: Nationwide within the United States
Lot/code information: Part Number: 077-60621, Lot #: 23JK02010, Exp. Date 1/31/2025
Quantity: 69,590 bags
Status: Ongoing
Products in this recall event:
- 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. (D-0218-2024)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.