DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, 2L 5PK, Part Number 054-20221, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.

Recall Number: D-0512-2026

Firm: Fresenius Medical Care Holdings, Inc.

Classification: Class II

Status: Ongoing

Report Date: 20260513

Initiation Date: 20260406

Termination Date:

Lack of Assurance of Sterility: Potential leaks from perforations in bags.

DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, 2L 5PK, Part Number 054-20221, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.