DELFLEX Peritoneal Dialysis Solution recalled over sterility concerns

Recall date

December 20, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Fresenius Medical Care Renal Therapies Group, LLC recalls DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged in a) 3L (4 pack, NDC 49230-209-30), b) 2…

Recall number

D-0604-2018

FDA classification

Class II

Brand / firm

Fresenius Medical Care Renal Therapies Group, LLC

Sold / distributed

Product was distributed throughout the United States to patients and clinics.

Why it was recalled

Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.