Recall Z-2321-2026
- Recall number
- Z-2321-2026
- Event number
- 98877
- Firm
- Fresenius Medical Care Holdings, Inc.
- Firm FEI
- 3001451489
- Product code
- KPO
- Status
- Open, Classified
- Initiated
- 2026-05-12
- Posted
- 2026-06-05
- Root cause
- Process design
- 510(k) numbers
- K233950, K243786, K192017, K922005, K864942, K102194, K861156, K854206, K191474, K193155, K901473, K171015, K050827, K212052, K052253, K162887, K180679, K982378, K120333, K160847, K834538, K993212, K223431, K982813, K910319, K813586, K792513, K034066, K090002, K012547
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.