Fresenius recalls Bicarby dialysate over leaks that can cause slip and fall hazard
The luer-lock connector on Bicarby dialysate can leak when users handle the frangible and tubing to prepare it for treatment, and fluid on the floor could cause someone to slip and fall.
What to do
The notice does not give instructions. Read the official notice for details.
Recall details
- Product
- Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;
- 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.
- Units
- 1,756,108 units
- Where sold
- US Nationwide distribution in the states of NY, TN and TX.
- FDA classification
- Class II · Ongoing
- Classified by FDA
- June 5, 2026
- Recall started
- May 12, 2026
- FDA enforcement report
- June 17, 2026
- Identifiers
- Codes: 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
- FDA recall number: Z-2321-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- Product
- Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;
- Reason for recall
- 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.
- Classification
- Class II (Ongoing)
- Distribution
- US Nationwide distribution in the states of NY, TN and TX.
- Quantity
- 1,756,108 units
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