{"url_path":"/fda/drug/recalls/D-0512-2026","section_key":"summary","section_title":"DRUG Recall: Fresenius Medical Care Holdings, Inc. — DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only,  1.5% DEX. LM/LC, 2L 5PK, Part Number 054-20221, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.","topic":"fda","document":{"doc_type":"drug-recall","doc_date":"2026-04-06","source_url":"https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0512-2026%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":88,"has_tables":false,"body_markdown":"# FDA DRUG Recall: D-0512-2026\n\n**Recalling firm:** Fresenius Medical Care Holdings, Inc.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-04-06\n**Report date:** 2026-05-13\n\n## Product\nDELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only,  1.5% DEX. LM/LC, 2L 5PK, Part Number 054-20221, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.\n\n## Reason\nLack of Assurance of Sterility: Potential leaks from perforations in bags.\n\n## Affected lots\nLot #: 25CU02007, 25CU02008, 25CU02009\n\n## Distribution\nNationwide in the USA"}