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
Reason for recall: This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
Recall initiated: 20240618
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated