Official recall notice
FDA Recall: Medline Convenience Kits: 1) MULTIMED, 7FR, 20CM, 3L, CVC BUNDLE, Model Number: ECVC5995; 2) TRIP
- Recall date
- 2026-07-08
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
The 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.
Product description
The 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.
Affected products
1) 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