Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
DELFLEX Peritoneal Dialysis Solution Recalled by Fresenius Medical Care Renal Therapies Group, LLC Due to Lack of Assurance of Sterility: Leakage of the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Fresenius Medical Care Renal Therapies Group, LLC directly.
Affected Products
DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged in a) 3L (4 pack, NDC 49230-209-30), b) 2 L(6 pack NDC 49230-209-23), Rx only, Fresenius Medical Care NA, Waltham, MA 02451.
Quantity: 3,734 cases
Why Was This Recalled?
Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag.
Where Was This Sold?
Product was distributed throughout the United States to patients and clinics.
About Fresenius Medical Care Renal Therapies Group, LLC
Fresenius Medical Care Renal Therapies Group, LLC has 27 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report