Data Composite

Recall D-0608-2024

US Class II Ongoing · initiated 2024-06-18

Recalling firm

Fresenius Medical Care Holdings, Inc., MA

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.

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