FDA Issues Class II Recall for Peritoneal Dialysis Solutions Due to Potential Sterility Breach

Key Takeaways

• The US Food and Drug Administration (FDA) is monitoring a voluntary, firm-initiated Class II recall of DELFLEX peritoneal dialysis solutions (1.5% and 2.5% dextrose, 2L 5-pack), involving over 80 000 bags distributed nationwide and identified across multiple lots including 25CU02007–25CU02009 and 25CU02002, 25CU02011–25CU02013.
• The recall was initiated by Fresenius Medical Care Holdings, Inc. due to lack of assurance of sterility from potential bag leaks caused by perforations, a defect that may lead to temporary or medically reversible adverse health effects.
• DELFLEX peritoneal dialysis solution is used for intraperitoneal dialysis in patients with renal failure, commonly administered in home and clinical dialysis settings.

The FDA has classified a Class II recall for DELFLEX Dextrose Peritoneal Dialysis Solutions with attached stay-safe Exchange Sets, used for intraperitoneal dialysis. The recall includes 2 concentrations:

• 1.5% dextrose (Part #054-20221) – 37 215 bags, Lots 25CU02007, 25CU02008, 25CU02009
• 2.5% dextrose (Part #054-20222) – 43 225 bags, Lots 25CU02002, 25CU02011, 25CU02012, 25CU02013

These products were manufactured and distributed by Fresenius Medical Care Holdings, Inc., Waltham, MA, and distributed nationwide in the US. The recall was initiated on April 6, 2026.

The recall was prompted by a lack of assurance of sterility, specifically due to potential leaks from perforations in the dialysis solution bags. Compromised container integrity raises concerns for contamination during use. The FDA classified the recall as Class II on May 4, 2026, indicating that use of the affected product may cause temporary or medically reversible adverse health consequences, though the risk of serious harm is considered low. The firm notified consignees via letter; no public press release has been issued.

DELFLEX peritoneal dialysis solutions are used in the management of patients with end-stage renal disease (ESRD) requiring peritoneal dialysis, allowing removal of waste products and excess fluid via the peritoneal cavity. These solutions are commonly used in home dialysis and outpatient nephrology settings. Pharmacists and dialysis providers should identify and quarantine affected lots, ensure removal from inventory, and coordinate replacement supply to avoid treatment disruption. Because sterility is critical in dialysis solutions, compromised bags may increase the risk of peritonitis or infection, necessitating prompt action.

Reference
FDA. Enforcement Report. May 7, 2026. Accessed May 7, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=219904; https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=219905