FDA Drug Class II — Moderate

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.

Hazard

Lack of Sterility Assurance

Products

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.
Brand
Fresenius Medical Care Holdings, Inc.
UPC
Part Number: 077-60621, Lot #: 23JK02010, Exp. Date 1/31/2025

Units Affected

69,590 bags