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;
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) 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
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model 1) ECVC5995Model UDI-DI: 10653160338970(each)Model 00653160338973(case)Model Lot Number: 2026011990Model 2) ECVC2625Model UDI-DI: 10653160334255(each)Model 00653160334258(case)Model Lot Number: 2025121990Model 3) STCVC26USModel UDI-DI: 10653160343424(each)Model 00653160343427(case)Model Lot Number: 2026010290Model 4) ECVC3720Model UDI-DI: 10653160341499(each)Model 00653160341492(case)Model Lot Number: 2025123090Model 5) 3K16H1838Model UDI-DI: 10653160341260(each)Model 00653160341263(case)Model Lot Number: 2025120590Model 6) ECVC5610Model UDI-DI: 10653160335047(each)Model 00653160335040(case)Model Lot Number: 2025122290Model 7) ECVC3810UPC 10653160338970UPC 00653160338973UPC 10653160334255UPC 00653160334258UPC 10653160343424UPC 00653160343427UPC 10653160341499UPC 00653160341492UPC 10653160341260UPC 00653160341263UPC 10653160335047UPC 00653160335040UPC 10653160336013UPC 00653160336016UPC 10653160336570UPC 00653160336573UPC 10653160334217UPC 00653160334210UPC 10653160336150UPC 00653160336153UPC 10653160344933UPC 00653160344936UPC 10653160358992Would you have heard about this one?
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