DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged in a) 3L (4 pack, N...
FDA Recall #D-0604-2018 — Class II — December 20, 2017
Product Description
DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged in a) 3L (4 pack, NDC 49230-209-30), b) 2 L(6 pack NDC 49230-209-23), Rx only, Fresenius Medical Care NA, Waltham, MA 02451.
Reason for Recall
Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag.
Recalling Firm
Fresenius Medical Care Renal Therapies Group, LLC — Waltham, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
3,734 cases
Distribution
Product was distributed throughout the United States to patients and clinics.
Code Information
Lot #: a) 17KU03006, 7KU03007; b) 17KU03004, 17KU03005, Exp.08/2019
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated