DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, 2000 mL, packs of 5, Rx only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-212-92

Recall Number: D-0609-2021

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 4.25% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, 2000 mL, packs of 5, Rx only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-212-92