Medline Convenience Kits: 1) ARTERIAL LINE KIT, Model Number: ART890B; 2) ULTRASOUND GUIDED IV SECUREMENT SET, Model Number: IVS3350
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 LINE KIT, Model Number: ART890B; 2) ULTRASOUND GUIDED IV SECUREMENT SET, Model Number: IVS3350
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model 1) ART890BModel UDI-DI: 10653160360834(each)Model 00653160360837(case)Model Lot Number: 2025102390Model 2) IVS3350Model UDI-DI: 10653160313045(each)Model 00653160313048(case)Model Lot Number: 2025102490UPC 10653160360834UPC 00653160360837UPC 10653160313045UPC 00653160313048Would 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.