US Drug Recall Register
Class II · Moderate risk Ongoing Initiated Dec 28, 2023 (3 years ago)

DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in…

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

Why it was recalled

Lack of Sterility Assurance

What was recalled

DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Medical Care NA Waltham, MA 02451, NDC 49230-206-62.

Recalling firm
Fresenius Medical Care Holdings, Inc.
NDC code
49230-206-62
Origin
MA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0218-2024

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.