Fresenius Bicarby Dialysate recalled for luer-lock leak and slip hazard risk
Fresenius Medical Care is notifying users of potential leaks in Bicarby Dialysate products during setup and use. Fluid leaks from the luer-lock connection can create a slip and fall hazard on the floor where treatment is taking place.
From the FDA notice · Read the official notice ↗ · All Fresenius Medical Care recalls
What to do
- Check your dialysate product model number against the recall list (RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, RFP-456-G).
- Contact Fresenius Medical Care or your healthcare provider for guidance on use or replacement.
- Be alert for leaks when preparing or handling the product and clean up any spilled fluid immediately.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 1,756,108 units
- Illnesses reported
- None reported
- Manufactured in
- 920 Winter St Bld 920, N/A, Waltham, MA, United States
- Classification
- Class II
- Recall number
- Z-2321-2026
In the FDA's words
- Description
- Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G; 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. Model Number: RFP-400-G; UDI-DI: 00840861102839; 2. Model Number: RFP-401-G; UDI-DI: 00840861102853; 3. Model Number: RFP-402-G; UDI-DI: 00840861102822; 4. Model Number: RFP-404-G; UDI-DI: 00840861102914; 5. Model Number: RFP-407-G; UDI-DI: 00840861102846: 6. Model Number: RFP-456-G; UDI-DI: 00840861102945; All lots produced from January 13, 2025, through lot 26AG02019 on January 13, 2026 Distribution: US Nationwide distribution in the states of NY, TN and TX. Affected quantity: 1,756,108 units
- Hazard
- 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.