[pending] Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-4
Pending LLM rewrite. Source: FDA_DEVICE Z-2321-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
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;
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- 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
Distributed nationwide across the United States.
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