DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack, Rx Only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-0188-50

Recall Number: D-0604-2021

Firm: Fresenius Medical Care Holdings, Inc.

Classification: Class III

Status: Terminated

Report Date: 20210616

Initiation Date: 20210428

Termination Date: 20210917

Temperature Abuse: Product exposed to temperature outside specified limits.

DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack, Rx Only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-0188-50