{"url_path":"/fda/device/recalls/Z-3000-2026","section_key":"summary","section_title":"DEVICE Recall: American Contract Systems Inc — American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AM","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-06-29","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3000-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"American Contract Systems Inc"},"word_count":95,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-3000-2026\n\n**Recalling firm:** American Contract Systems Inc\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-06-29\n**Report date:** 2026-09-02\n\n## Product\nAmerican Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AM\n\n## Reason\nThe Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.\n\n## Affected lots\nLot Code: Lot Number: 42-8493811 UDI: 191072232991 Expiration Date: 7/15/2026\n\n## Distribution\nUS Nationwide distribution in the states of IA, OH."}