Medline Convenience Kits: 1) ARTERIAL ACCESS TRAY W/LIDOCAINE, Model Number: ART1145; 2) Universal Central/Art Line Insertion Kit, Model Number: ART155A; 3) ARTERIAL LINE INSERTION TRAY, Model Number: ART1010B
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) ARTERIAL ACCESS TRAY W/LIDOCAINE, Model Number: ART1145; 2) Universal Central/Art Line Insertion Kit, Model Number: ART155A; 3) ARTERIAL LINE INSERTION TRAY, Model Number: ART1010B
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model 1) ART1145Model UDI-DI: 10653160349259(each)Model 00653160349252(case)Model Lot Number: 2025120590Model 2) ART1145Model Lot Number: 2025101490Model 3) ART155AModel UDI-DI: 10653160316459(each)Model 00653160316452(case)Model Lot Number: 2025100890Model 4) ART1010BModel UDI-DI: 10653160353577(each)Model 00653160353570(case)Model Lot Number: 2025091590UPC 10653160349259UPC 00653160349252UPC 10653160316459UPC 00653160316452UPC 10653160353577UPC 00653160353570Would you have heard about this one?
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Start monitoring freeSourced from the Food and Drug Administration’s public recall data. Always verify serial and date ranges against the official notice before acting.