Medline Convenience Kits recalled due to Lidocaine quality issues
Medline Industries is recalling two convenience kits (Arterial Line Kit and Ultrasound Guided IV Securement Set) due to quality issues with included Lidocaine Ampules identified during an FDA inspection.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is FDA Class II, a device recall. The source text does not report any illnesses, injuries, or hospitalizations related to the quality issues, making this a precautionary/quality-control recall without confirmed adverse events.
Plain-English summary
Medline Industries, LP is recalling 250 kits nationwide, comprising two products: the Arterial Line Kit (Model ART890B, Lot 2025102390) and the Ultrasound Guided IV Securement Set (Model IVS3350, Lot 2025102490). These kits contain Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules as a component.
The recall was initiated due to quality issues identified during an FDA manufacturing inspection of Huons Co., Ltd.'s drug manufacturing site. The source text does not specify the nature of the quality issues, reported illnesses or injuries, or what actions patients or healthcare providers should take regarding existing product use.
Patients and healthcare providers should contact Medline Industries for further guidance regarding this recall and any affected kits already in use.
The recalled product
- Product
- Medline Convenience Kits: 1) ARTERIAL LINE KIT, Model Number: ART890B; 2) ULTRASOUND GUIDED IV SECUREMENT SET, Model Number: IVS3350
- Manufacturer
- Medline Industries, LP
- Hazard
- quality-defect
- drug-component
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- 1) ART890B
- UDI-DI: 10653160360834(each)
- 00653160360837(case)
- Lot Number: 2025102390
- 2) IVS3350
- UDI-DI: 10653160313045(each)
- 00653160313048(case)
- Lot Number: 2025102490
Distribution
Distributed nationwide across the United States.
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