Bicarby dialysate luer-lock connections may leak fluid onto floors
Bicarby Dialysate across six model numbers is being recalled because luer-lock leaks during preparation present a potential slip and fall hazard from fluid on the floor.
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: FDA Class II recall with a stated slip and fall hazard from leaked fluid, a risk of harm with no injuries reported in the source.
Plain-English summary
Bicarby Dialysate from Fresenius Medical Care Holdings, Inc., model numbers RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G and RFP-456-G, is being recalled. The action covers 1,756,108 units.
Given an increased number of leaks reported by users, the manufacturer determined it was appropriate to notify users of the potential for Bicarby luer-lock leaks during manipulation of the frangible and tubing when preparing the product for use in treatment. According to the manufacturer, this issue presents the potential of a slip and fall hazard associated with fluid on the floor. The FDA classified the action as Class II.
Distribution was within the United States, in New York, Tennessee and Texas. The dialysate is supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the model numbers and UDI-DI codes in the recall notice and follow the instructions issued by Fresenius Medical Care.
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 — Dialysate
- Affected units
- 1,756,108
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
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