{"url_path":"/fda/device/recalls/Z-2143-2026","section_key":"summary","section_title":"DEVICE Recall: Medline Industries, LP — Medline medical convenience kits, containing Namic Manifold, Labeled as:    1. ANGIOGRAPHY CATH LAB, Medline Kit Number/SKUDYNJ23532C;   2. CATH LAB PACK, Medline Kit Number/SKUDYNJ65185;   3. ANGIO KIT, Medline Kit Number/SKUVASC1057.","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-03-24","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2143-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Medline Industries, LP"},"word_count":178,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2143-2026\n\n**Recalling firm:** Medline Industries, LP\n**Classification:** Class I\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-03-24\n**Report date:** 2026-05-20\n\n## Product\nMedline medical convenience kits, containing Namic Manifold, Labeled as:    1. ANGIOGRAPHY CATH LAB, Medline Kit Number/SKUDYNJ23532C;   2. CATH LAB PACK, Medline Kit Number/SKUDYNJ65185;   3. ANGIO KIT, Medline Kit Number/SKUVASC1057.\n\n## Reason\nMedline has identified the presence of particulate within the fluid path of the Manifolds.\n\n## Affected lots\nMedline Kit Number/SKU DYNJ23532C:  UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number: 25DMA809;  Medline Kit Number/SKU DYNJ65185:  UDI/DI each 10193489253146, UDI/DI case 40193489253147, Lot Number: 23GBA252;  Medline Kit Number/SKU DYNJ65185:  UDI/DI each 10193489253146, UDI/DI case 40193489253147, Lot Number: 23HBI873;  Medline Kit Number/SKU DYNJ65185:  UDI/DI each 10193489253146, UDI/DI case 40193489253147, Lot Number: 23IBR043;  Medline Kit Number/SKU DYNJ65185:  UDI/DI each 10193489253146, UDI/DI case 40193489253147, Lot Number: 23KBF277;  Medline Kit Number/SKU DYNJ65185:  UDI/DI each 10193489253146, UDI/DI case 40193489253147, Lot Number: 24ABQ959;  Medline Kit Number/SKU VASC1057:  UDI/DI each 10889942431922, UDI/DI case 40889942431923, Lot Number: 25KMF194.\n\n## Distribution\nUS (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK."}