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 INSERTIO
Medline Industries, LP
The 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. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
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
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model 1) SUT12260Model UDI-DI: 00653160130942(each)Model 10653160130949(case)Model Lot Number: 2026031190Model 2) MNS3390Model UDI-DI: 00653160100433(each)Model 10653160100430(case)Model Lot Number: 2025120590Model 3) MNS9715Model UDI-DI: 10653160292029(each)Model 00653160292022(case)Model Lot Number: 2025120890Model 4) ART351Model UDI-DI: 10653160323754(each)Model 00653160323757(case)Model Lot Number: 2025120990Model 5) P155615AModel UDI-DI: 10889942219889(each)Model 40889942219880(case)Model 6) MNS3390Model Lot Number: 2025102790Model 7) SUT18660AUPC 00653160130942UPC 10653160130949UPC 00653160100433UPC 10653160100430UPC 10653160292029UPC 00653160292022UPC 10653160323754UPC 00653160323757UPC 10889942219889UPC 40889942219880UPC 10653160359302UPC 00653160359305UPC 00653160204407UPC 10653160204404UPC 10884389278352UPC 40884389278353UPC 10653160312727UPC 00653160312720UPC 10653160331254Would you have heard about this one?
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