- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- 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.
- Affected products (lot / model / serial)
- 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
- Units affected
- 1,756,108 units
- Distribution pattern
- US Nationwide distribution in the states of NY, TN and TX.
- Firm location
- Waltham, MA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2321-2026
- Recall initiated
- May 12, 2026
- FDA classification date
- June 5, 2026
- FDA report date
- June 17, 2026
- FDA event ID
- 98877
- Last updated on HTM Vibe
- July 23, 2026