Medline Convenience Kits: 1) SUTURE TRAY, Model Number: SUT12260; 2) CHEST TUBE INSERTION TRAY, Model Number: MNS3390; 3) CONTRACEPTIVE IMPLANT INSERTION KIT, Model Number: MNS9715; 4) 20GX3" RADIAL ART LINE KIT, Model Number: ART351; 5) MYELOGRAM PACK, Model Number: P155615A; 6) CHEST TUBE INSERTION TRAY, Model Number: MNS3390; 7) LACERATION TRAY, Model Number: SUT18660A; 8) GENERAL BIOPSY TRAY, Model Number: MNS5985; 9) LACERATION TRAY, Model Number: DYNDL1351; 10) 20GX3" RADIAL ART LINE KIT, Model Number: ART351; 11) ARTERIAL LINE TRAY, Model Number: ART600; 12) SUTURE TRAY, Model Number: SUT12260; 13) ER SUTURING TRAY, Model Number: SUT9710C; 14) INCISION & DRAINAGE TRAY, Model Number: ID2060; 15) LACERATION TRAY - SNAG FREE, Model Number: SUT12265; 16) BIOPSY TRAY, Model Number: DYNDH1466; 17) GENERAL BIOPSY TRAY, Model Number: MNS5985; 18) SUTURE SET, Model Number: SUT19665; 19) MYELOGRAM-LF SAFE PACK, Model Number: P124863; 20) 20GX3" RADIAL ART LINE KIT, Model Number: ART351; 21) LACERATION TRAY, Model Number: SUT18660A; 22) 20GX6" FEMORAL ART LINE KIT, Model Number: ART352; 23) BIOPSY PACK, Model Number: DYNDH1699; 24) SUTURE TRAY, Model Number: SUT12260; 25) CHEST TUBE INSERTION TRAY, Model Number: MNS3390; 26) ARTHROGRAM TRAY, Model Number: SPEC0070B; 27) SUTURING SET, Model Number: SUT4155; 28) SUTURE TRAY, Model Number: SUT16080; 30) MYELOGRAM TRAY CHOICE, Model Number: DYNDH1213; 31) MYELOGRAM PACK, Model Number: P155615A; 32) LACERATION TRAY - SNAG FREE, Model Number: SUT12265

Official details

Category

Medical device recall

Status

Ongoing

Classification

Class II

Company or vendor

Medline Industries, LP

Affected product

US Nationwide distribution.

Risk or reason

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.

Remedy or action

1) SUT12260, UDI-DI: 00653160130942(each), 10653160130949(case), Lot Number: 2026031190; 2) MNS3390, UDI-DI: 00653160100433(each), 10653160100430(case), Lot Number: 2025120590; 3) MNS9715, UDI-DI: 10653160292029(each), 00653160292022(case), Lot Number: 2025120890; 4) ART351, UDI-DI: 10653160323754(each), 00653160323757(case), Lot Number: 2025120990; 5) P155615A, UDI-DI: 10889942219889(each), 40889942219880(case), Lot Number: 2025120890; 6) MNS3390, UDI-DI: 00653160100433(each), 10653160100430(case), Lot Number: 2025102790; 7) SUT18660A, UDI-DI: 10653160359302(each), 00653160359305(case), Lot Number: 2025120890; 8) MNS5985, UDI-DI: 00653160204407(each), 10653160204404(case), Lot Number: 2025120590; 9) DYNDL1351, UDI-DI: 10884389278352(each), 40884389278353(case), Lot Number: 2025120190; 10) ART351, UDI-DI: 10653160323754(each), 00653160323757(case), Lot Number: 2025112690; 11) ART600, UDI-DI: 10653160312727(each), 00653160312720(case), Lot Number: 2025112690; 12) SUT12260, UDI-DI: 00653160130942(each), 10653160130949(case), Lot Number: 2025112690; 13) SUT9710C, UDI-DI: 10653160331254(each), 00653160331257(case), Lot Number: 2025103090; 14) ID2060, UDI-DI: 10653160310006(each), 00653160310009(case), Lot Number: 2025101790; 15) SUT12265, UDI-DI: 00653160130898(each), 10653160130895(case), Lot Number: 2025102390; 16) DYNDH1466, UDI-DI: 10193489193756(each), 20193489193753(case), Lot Number: 2025102190; 17) MNS5985, UDI-DI: 00653160204407(each), 10653160204404(case), Lot Number: 2025101690; 18) SUT19665, UDI-DI: 10653160288572(each), 00653160288575(case), Lot Number: 2025102490; 19) P124863, UDI-DI: 10889942140787(each), 40889942140788(case), Lot Number: 2025102090; 20) ART351, UDI-DI: 10653160323754(each), 00653160323757(case), Lot Number: 2025101090; 21) SUT18660A, UDI-DI: 10653160359302(each), 00653160359305(case), Lot Number: 2025092690; 22) ART352, UDI-DI: 10653160323747(each), 00653160323740(case), Lot Number: 2025100790; 23) DYNDH1699, UDI-DI: 10653160349914(each), 00653160349917(case), Lot Number: 2025092590; 24) SUT12260, UDI-DI: 00653160130942(each), 10653160130949(case), Lot Number: 2025092690; 25) MNS3390, UDI-DI: 00653160100433(each), 10653160100430(case), Lot Number: 2025091590; 26) SPEC0070B, UDI-DI: 10193489196627(each), 20193489196624(case), Lot Number: 2025100890; 27) SUT4155, UDI-DI: 00653160008760(each), 50653160008765(case), Lot Number: 2025100990; 28) SUT16080, UDI-DI: 00653160225051(each), 10653160225058(case), Lot Number: 2025092690; 29) DYNDH1213, UDI-DI: 10653160383864(each), 00653160383867(case), Lot Number: 2025091990; 30) P155615A, UDI-DI: 10889942219889(each), 40889942219880(case), Lot Number: 2025090490; 31) SUT12265, UDI-DI: 00653160130898(each), 10653160130895(case), Lot Number: 2025090590

Official ID

Z-2542-2026