Recall Z-2321-2026 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Fresenius Medical Care Holdings, Inc.
Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;
| Date | Jun 5, 2026 (initiated May 12, 2026) |
| Status | Open, Classified |
| Reason | Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer-lock leaks during manipulation of the frangible and tubing when preparing the product for use for treatment. This issue presents the potential of a slip and fall hazard associated with fluid on the floor. |
| Root cause | Process design |
| Action | On 5/12/2026 an IMPORTANT MEDICAL DEVICE INFORMATION letters were sent to customers to inform them that manipulation of the luer-lock location during treatment preparation may result in fluid spillage onto the user and floor. This occurs prior to treatment and renders the product unusable. Direct contact with the fluid does not present any risk to the user as frangible manipulation only occurs after the peal seam has been broken and the two fluid compartments have been mixed. The potential risk associated with the affected Bicarby Dialysate product is a slip and fall hazard due to the presence |
| Quantity | 1,756,108 units |
| Distribution | US Nationwide distribution in the states of NY, TN and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K233950 | pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070) Fresenius Medical Care Renal Therapies Group, LLC, May 10, 2024 |
| K243786 | Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bic Fresenius Medical Care Renal Therapies Group, LLC, Apr 4, 2025 |