{"url_path":"/fda/device/recalls/Z-2296-2026","section_key":"summary","section_title":"DEVICE Recall: Bayer Medical Care, Inc. — Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad¿ Avanta Injection System;  Catalog number: AVA 500 MPAT (Part 2 of 2);  Affected material numbers: 87629007, 60729458, 86566648;","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-04-24","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2296-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Bayer Medical Care, Inc."},"word_count":226,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2296-2026\n\n**Recalling firm:** Bayer Medical Care, Inc.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-04-24\n**Report date:** 2026-06-10\n\n## Product\nAvanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad¿ Avanta Injection System;  Catalog number: AVA 500 MPAT (Part 2 of 2);  Affected material numbers: 87629007, 60729458, 86566648;\n\n## Reason\nSupplier changes resulted in a fit issue with the Contrast Flow Control Valve (CFCV) interface on the Avanta Injector System. Multiple customer reports indicate that the stopcock cannot be reliably engaged with the CFCV snap interface. In instances where engagement is achieved through applied force, the connection is unstable, and the stopcock may disengage before or during contrast injection, leading to procedure interruption.\n\n## Affected lots\nCatalog number: AVA 500 MPAT (Part 2 of 2) Affected material numbers: 87629007, 60729458, 86566648; Affected batch numbers: 251702, 252302, 252502, 252602, 252702, 252802, 253304, 253702, 253704, 253804, 254202, 254304, 254704, 254802;\n\n## Distribution\nWorldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DE, FL, IA, IL, IN, KS, KY, LA, MA, MD, ME, MO, NC, NY, OH, OK, PA, SC, TN, TX, VA, WI and the countries of AE, BA, BE, CA, CH, CN, DE, DK, ES, FR, GB, HK, HR, IL, KW, MT, MX, NL, RO, RU, SE, ZA."}