{"url_path":"/fda/device/recalls/Z-2536-2026","section_key":"summary","section_title":"DEVICE Recall: Medline Industries, LP — Medline Convenience Kits:  1) MULTIMED, 7FR, 20CM, 3L, CVC BUNDLE, Model Number: ECVC5995;   2) TRIPLE LUMEN CENTRAL LINE BUNDLE, Model Number: ECVC2625;   3) INTROFLEX 6F, 1L, TB, US, Model Number: STCVC26US;   4) AVA HIGH FLOW, Model Number: ECVC3720;   5) CDP, MM, 3L, 7F, 16CM, H, Model Number: 3K16H1838;   6) CVC Insertion Bundle 3L 7FR 20CM, Model Numb…","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-05-21","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2536-2026%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":671,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2536-2026\n\n**Recalling firm:** Medline Industries, LP\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-05-21\n**Report date:** 2026-07-08\n\n## Product\nMedline Convenience Kits:  1) MULTIMED, 7FR, 20CM, 3L, CVC BUNDLE, Model Number: ECVC5995;   2) TRIPLE LUMEN CENTRAL LINE BUNDLE, Model Number: ECVC2625;   3) INTROFLEX 6F, 1L, TB, US, Model Number: STCVC26US;   4) AVA HIGH FLOW, Model Number: ECVC3720;   5) CDP, MM, 3L, 7F, 16CM, H, Model Number: 3K16H1838;   6) CVC Insertion Bundle 3L 7FR 20CM, Model Number: ECVC5610;   7) TRIPLE LUMEN CVC INSERTION BUNDLE, Model Number: ECVC3810;   8) 16CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number: ECVC2555;   9) CENTRAL LINE BUNDLE W/7F, 20CM, 3L, Model Number: ECVC2750;   10) TRIPLE LUMEN COMPLETE CATH KIT, Model Number: ECVC5200;   11) TRIPLE LUMEN CVC 20CM BUNDLE W/O SUTURE, Model Number: ECVC7290;   12) AVA HIGH FLOW, Model Number: ECVC3720;   13) 7FR 3L 16CM CVC INSERTION BUNDLE, Model Number: ECVC8215;   14) CENTRAL LINE INSERTION BUNDLE, Model Number: ECVC2080;   15) 3L 7FR 16 CM CVC INSERTION TRAY, Model Number: ECVC8165;   16) VANTEX 7FR 3L 20CM CVC BUNDLE, Model Number: ECVC6505;   17) VANTEX 7FR, 16CM, 3L CVC BUNDLE, Model Number: STCVC02;   18) O.R. CVC TRIPLE LUMEN BUNDLE, Model Number: ECVC1377;   19) INTROFLEX 8.5FR. 1L CVC BUNDLE, Model Number: CMPI851LBA;   20) INTROFLEX 5F, 1L, TB, US, BAS, Model Number: STCVC49US;   21) CVC BUNDLE, Model Number: ECVC8090;   22) TRIPLE LUMEN INSERTION KIT W/CATHETER, Model Number: ECVC2885;   23) O.R. CVC TRIPLE LUMEN BUNDLE, Model Number: ECVC1377;   24) MULTIMED, 7FR, 20CM, 3L, CVC BUNDLE, Model Number: ECVC5995;   25) 3L 7FR 20CM CVC INSERTION BUNDLE, Model Number: ECVC6845;   26) CVC BUNDLE TRIPLE LUMEN 16CM, Model Number: ECVC5540A;   27) CDP, MM, 3L, 7F, 16CM, H, Model Number: 3K16H1838;   28) CVC INSERTION BUNDLE, Model Number: ECVC1120;   29) TRIPLE LUMEN CENTRAL LINE BUNDLE, Model Number: ECVC2625;   30) TRIPLE LUMEN COMPLETE CATH KIT, Model Number: ECVC5200;   31) VANTEX 7FR 3L 16CM CVC BUNDLE W/US, Model Number: ECVC8075;   32) CENTRAL LINE BUNDLE W/7F, 16CM, 3L, Model Number: ECVC2745;   33) VANTEX 7FR 3L 16CM CVC BUNDLE W/US, Model Number: ECVC7945;   34) CENTRAL LINE BUNDLE W/7F, 20CM, 3L, Model Number: ECVC2750\n\n## Reason\nThe kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.\n\n## Affected lots\n1) ECVC5995, UDI-DI: 10653160338970(each), 00653160338973(case), Lot Number: 2026011990; 2) ECVC2625, UDI-DI: 10653160334255(each), 00653160334258(case), Lot Number: 2025121990; 3) STCVC26US, UDI-DI: 10653160343424(each), 00653160343427(case), Lot Number: 2026010290; 4) ECVC3720, UDI-DI: 10653160341499(each), 00653160341492(case), Lot Number: 2025123090; 5) 3K16H1838, UDI-DI: 10653160341260(each), 00653160341263(case), Lot Number: 2025120590; 6) ECVC5610, UDI-DI: 10653160335047(each), 00653160335040(case), Lot Number: 2025122290; 7) ECVC3810, UDI-DI: 10653160336013(each), 00653160336016(case), Lot Number: 2025102390; 8) ECVC2555, UDI-DI: 10653160336570(each), 00653160336573(case), Lot Number: 2025121190; 9) ECVC2750, UDI-DI: 10653160334217(each), 00653160334210(case), Lot Number: 2025102490; 10) ECVC5200, UDI-DI: 10653160336150(each), 00653160336153(case), Lot Number: 2025101490; 11) ECVC7290, UDI-DI: 10653160344933(each), 00653160344936(case), Lot Number: 2025101490; 12) ECVC3720, UDI-DI: 10653160341499(each), 00653160341492(case), Lot Number: 2025101690; 13) ECVC8215, UDI-DI: 10653160358992(each), 00653160358995(case), Lot Number: 2025101790; 14) ECVC2080, UDI-DI: 10653160334408(each), 00653160334401(case), Lot Number: 2025101690; 15) ECVC8165, UDI-DI: 10653160358749(each), 00653160358742(case), Lot Number: 2025101390; 16) ECVC6505, UDI-DI: 10653160336327(each), 00653160336320(case), Lot Number: 2025101490; 17) STCVC02, UDI-DI: 10653160336822(each), 00653160336825(case), Lot Number: 2025101690; 18) ECVC1377, UDI-DI: 10653160332152(each), 00653160332155(case), Lot Number: 2025101690; 19) CMPI851LBA, UDI-DI: 10653160347453(each), 00653160347456(case), Lot Number: 2025090290; 20) STCVC49US, UDI-DI: 10653160347972(each), 00653160347975(case), Lot Number: 2025092390; 21) ECVC8090, UDI-DI: 10653160357667(each), 00653160357660(case), Lot Number: 2025091990; 22) ECVC2885, UDI-DI: 10653160335405(each), 00653160335408(case), Lot Number: 2025092490; 23) ECVC1377, UDI-DI: 10653160332152(each), 00653160332155(case), Lot Number: 2025092290; 24) ECVC5995, UDI-DI: 10653160338970(each), 00653160338973(case), Lot Number: 2025100790; 25) ECVC6845, UDI-DI: 10653160339366(each), 00653160339369(case), Lot Number: 2025091590; 26) ECVC5540A, UDI-DI: 10653160335009(each), 00653160335002(case), Lot Number: 2025092990; 27) 3K16H1838, UDI-DI: 10653160341260(each), 00653160341263(case), Lot Number: 2025092490; 28) ECVC1120, UDI-DI: 10653160334644(each), 00653160334647(case), Lot Number: 2025091990; 29) ECVC2625, UDI-DI: 10653160334255(each), 00653160334258(case), Lot Number: 2025091990; 30) ECVC5200, UDI-DI: 10653160336150(each), 00653160336153(case), Lot Number: 2025090390; 31) ECVC8075, UDI-DI: 10653160357124(each), 00653160357127(case), Lot Number: 2025091090; 32) ECVC2745, UDI-DI: 10653160334224(each), 00653160334227(case), Lot Number: 2025091190; 33) ECVC7945, UDI-DI: 10653160353966(each), 00653160353969(case), Lot Number: 2025091190; 34) ECVC2750, UDI-DI: 10653160334217(each), 00653160334210(case), Lot Number: 2025091090\n\n## Distribution\nUS Nationwide distribution."}