{"url_path":"/fda/device/recalls/Z-2103-2026","section_key":"summary","section_title":"DEVICE Recall: Medline Industries, LP — Medline Convenience Kits:  1) CENTRAL LINE UNIVERSAL INSERTI, Model Number: CVI3780;   2) LVAD DRIVELINE TRAY, Model Number: DM1035;   3) KIT SURG ONC INSERT CENT.VENOU, Model Number: DYKMBNDL43","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-01-07","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2103-2026%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":208,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2103-2026\n\n**Recalling firm:** Medline Industries, LP\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-01-07\n**Report date:** 2026-05-13\n\n## Product\nMedline Convenience Kits:  1) CENTRAL LINE UNIVERSAL INSERTI, Model Number: CVI3780;   2) LVAD DRIVELINE TRAY, Model Number: DM1035;   3) KIT SURG ONC INSERT CENT.VENOU, Model Number: DYKMBNDL43\n\n## Reason\nMedline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.\n\n## Affected lots\n1) CVI3780, UDI-DI: 10193489434866(each), 40193489434867(case), Lot Number: 23KBO637; 2) CVI3780, UDI-DI: 10193489434866(each), 40193489434867(case), Lot Number: 24ABC276; 3) DM1035, UDI-DI: 10193489442755(each), 40193489442756(case), Lot Number: 21BBN221; 4) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case), Lot Number: 21ABJ003; 5) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case), Lot Number: 21ABO838; 6) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case), Lot Number: 21DBD662; 7) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case), Lot Number: 21IBJ337; 8) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case), Lot Number: 21JBJ253; 9) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case), Lot Number: 22CBU342; 10) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case), Lot Number: 22EBL039; 11) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case), Lot Number: 22GBF510; 12) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case), Lot Number: 22GBN333\n\n## Distribution\nWorldwide - US Nationwide distribution."}