FDA Drug Moderate Class II Terminated

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.

Reported: March 28, 2018 Initiated: December 20, 2017 #D-0604-2018

Product Description

Reason for Recall

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

Details

Recalling Firm: Fresenius Medical Care Renal Therapies Group, LLC
Units Affected: 3,734 cases
Distribution: Product was distributed throughout the United States to patients and clinics.
Location: Waltham, MA

Frequently Asked Questions

What product 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.. Recalled by Fresenius Medical Care Renal Therapies Group, LLC. Units affected: 3,734 cases.

Why was this product recalled? ▼

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

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on March 28, 2018. Severity: Moderate. Recall number: D-0604-2018.