US Drug Recall Register
Class II · Moderate risk Ongoing Initiated Jun 18, 2024 (2 years ago)

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

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

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.

What was recalled

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 firm
Fresenius Medical Care Holdings, Inc.
NDC code
49230-212-94
Origin
MA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0608-2024

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.

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