{"url_path":"/fda/device/recalls/Z-2321-2026","section_key":"summary","section_title":"DEVICE Recall: 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;","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-05-12","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2321-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Fresenius Medical Care Holdings, Inc."},"word_count":170,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2321-2026\n\n**Recalling firm:** Fresenius Medical Care Holdings, Inc.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-05-12\n**Report date:** 2026-06-17\n\n## Product\nBicarby\" Dialysate;  Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;\n\n## Reason\nGiven 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.\n\n## Affected lots\nModel 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\n\n## Distribution\nUS Nationwide distribution in the states of NY, TN and TX."}