{"url_path":"/fda/device/recalls/Z-3068-2026","section_key":"summary","section_title":"DEVICE Recall: Medline Industries, LP — Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators    OPEN HEART\t  \tCDS983348AA  \tCDS983348AB","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-07-20","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3068-2026%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":115,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-3068-2026\n\n**Recalling firm:** Medline Industries, LP\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-07-20\n**Report date:** 2026-09-09\n\n## Product\nMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators    OPEN HEART\t  \tCDS983348AA  \tCDS983348AB\n\n## Reason\nDownstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.\n\n## Affected lots\nCDS983348AA    UDI-DI 10195327385088    Lots 24IBK346   24JBK539;  CDS983348AB    UDI-DI 10198459136986    Lots 25CBF097   25HBB232   25HBB761   25HBH209   25HBU907   25JBQ176\n\n## Distribution\nUS Nationwide distribution."}