Class IIOngoing

DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and a… recall

FDA recall D-0608-2024 · initiated Jun 18, 2024

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.

Details

Product: DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange Set, 2500mL (Approx. 50 mL excess), Single Dose Container Sterile and Non-Pyrogenic, For Intraperitoneal Administration Only, Fresenius Medical Care NA Waltham, MA 02451, 1-800-323-5188 NDC 49230-212-94
Recalling company: Fresenius Medical Care Holdings, Inc.
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide
Initiated: Jun 18, 2024
FDA report date: Jul 24, 2024

This recall is linked to a product we cover: Delflex W/ Dextrose 4.25% Low Magnesium Low Calcium in Plastic Container →

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0608-2024 ↗

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