US Drug Recall Register
Class II · Moderate risk Ongoing Initiated Apr 6, 2026 (5 months ago)

DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

What was recalled

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.

Recalling firm
Fresenius Medical Care Holdings, Inc.
Origin
MA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0512-2026

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.