{"url_path":"/fda/device/recalls/Z-1970-2026","section_key":"summary","section_title":"DEVICE Recall: AVID Medical, Inc. — Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-03-13","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1970-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"AVID Medical, Inc."},"word_count":109,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-1970-2026\n\n**Recalling firm:** AVID Medical, Inc.\n**Classification:** Class I\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-03-13\n**Report date:** 2026-05-13\n\n## Product\nHalyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.\n\n## Reason\nPotential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.\n\n## Affected lots\n1. Model Number: EAMC1000-05. UDI-DI (Kit Lot Numbers): 10809160377314 (1573593, 1583827, 1609541, 1609725, 1612134, 1612516, 1619132, 1623384, 1627013, 1635459, 1672306, 1675159).   2. Model Number: WAFB208-02. UDI-DI (Kit Lot Numbers): 10809160424759 (1615954, 1653009).\n\n## Distribution\nUS distribution to FL, IL, MO, MS, NC, NE, TX."}