Z-2321-2026 Class II Ongoing
FDA device recall Z-2321-2026 was initiated by Fresenius Medical Care Holdings, Inc. on May 12, 2026 and is designated Class II. 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 m… The recall status is ongoing. Affected quantity: 1,756,108 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 17, 2026
- Initiation Date
- May 12, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,756,108 units
Product Description
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.
Distribution Pattern
US Nationwide distribution in the states of NY, TN and TX.
Code Information
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