{"url_path":"/fda/device/recalls/Z-3074-2026","section_key":"summary","section_title":"DEVICE Recall: Medline Industries, LP — Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators    DELUXE PRE OP KIT\t  \tDYKS2018    GENERAL PREOP KIT\t  \tDYKS1584A    PRE OP KIT\t  \tDYKS1216I  \t  PRE-OP KIT\t  \tDYKM1398B","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-3074-2026%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":145,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-3074-2026\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    DELUXE PRE OP KIT\t  \tDYKS2018    GENERAL PREOP KIT\t  \tDYKS1584A    PRE OP KIT\t  \tDYKS1216I  \t  PRE-OP KIT\t  \tDYKM1398B\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\nDYKS2018    UDI-DI 10198459188480    Lot 25GMI043    DYKS1584A    UDI-DI 10198459146633    Lots 24JBA740   25ABF244    DYKS1216I    UDI-DI 10198459362668    Lots 25GBP888   25JBD789   26ABL474   26CBF334   26DBD640   26EBB855   26FBC632    DYKM1398B    UDI-DI 10198459413827    Lots 25HBI183   25JBK222   25KBA990   25LBJ990   26BBI525   26CBJ249   26EBQ630   26FMF189\n\n## Distribution\nUS Nationwide distribution."}