Fresenius Medical Care Holdings, Inc.: Bicarby" Dialysate; Model Numbers: Rfp-400-g, Rfp-401-g, Rfp-402-g, Rfp-404-g, Rfp-407-g, And Rfp-456-g
Recall Summary Fresenius Medical Care is recalling Bicarby Dialysate products (models RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G) due to an increased number of leaks occurring at the luer-lock connection during product preparation. The leaking fluid can create a slip and fall hazard on the floor. The recall affects dialysis patients nationwide who received this product through distribution in New York, Tennessee, and Texas.
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- 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
- 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
- Category
- medical device recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-05-12
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of NY, TN and TX.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/2316d5ba-4dbf-49fb-91e4-a2686e8af13e