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.

FDA recall notice · announced March 28, 2018 · Fresenius Medical Care Renal Therapies Group

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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.

Notes

Distribution: Product was distributed throughout the United States to patients and clinics.
Lot/code information: Lot #: a) 17KU03006, 7KU03007; b) 17KU03004, 17KU03005, Exp.08/2019
Quantity: 3,734 cases
Status: Terminated
Products in this recall event:
- 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 0245 (D-0604-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.