Recall Z-2401-2026 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Fresenius Medical Care Holdings, Inc.
Bicarby Dialysate; Model number: RFP-400-G;
| Date | Jun 11, 2026 (initiated May 7, 2026) |
| Status | Open, Classified |
| Reason | There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the product code and the solution contained in the bag. In the event the incorrect GTIN labeling is used as the singular source for product identification, unrecognized use of a potassium solution with a concentration differing from the prescription may result. |
| Root cause | Process control |
| Action | On 5/7/2026 an URGENT MEDICAL DEVICE RECALL letters were sent to customers. At this time, FMCRTG is providing this recall notice to alert you of the potential risks associated with the labeling error, and to ask that you identify, segregate, and discontinue use of affected lots, 25SG06026 and 25SG06027, of RFP-400-G Bicarby Dialysate. FMCRTG is requiring the return of the affected Bicarby Dialysate lots. FMCRTG will replace all remaining stock of affected product lots. For product technical questions or concerns, please contact Technical Support at 1-800-323-2732 or Customer Support at 1-800-3 |
| Quantity | 4752 |
| Distribution | Domestic: TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| 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 |