FDAFDA · Food and drugs·Recall number D-0608-2024
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
Published July 24, 2024 · Recall initiated: June 18, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Distributor
- Nationwide
- Lot
- 24AU03024, exp. date 07/31/2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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