DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags,...
FDA Recall #D-0218-2024 — Class II — December 28, 2023
Product Description
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
Recalling Firm
Fresenius Medical Care Holdings, Inc. — Waltham, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
69,590 bags
Distribution
Nationwide within the United States
Code Information
Part Number: 077-60621, Lot #: 23JK02010, Exp. Date 1/31/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated