Class II

Drug Recall: DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2.5% DEX. LM/LC, 2L 5PK, Part Number 054-20222, Fresenius Medical Care North Amer

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, 2.5% DEX. LM/LC, 2L 5PK, Part Number 054-20222, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.

Distribution

Nationwide in the USA

States Affected

NATIONWIDE

Quantity Affected

43,225 bags

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0513-2026

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.