Class II

Drug Recall: 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 Ame

Fresenius Medical Care Holdings, Inc. · April 6, 2026

Reason for Recall

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

Product Description

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.

Distribution

Nationwide in the USA

States Affected

NATIONWIDE

Quantity Affected

37,215 bags

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0512-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Fresenius Medical Care Holdings, Inc. Drug Recall: 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 Ame | SafeCheck