Medline arterial access and insertion kits with lidocaine ampules recalled
Medline Industries is recalling three arterial access and insertion kits nationwide because they contain lidocaine ampules subject to a quality issue recall by the manufacturer Huons Co., Ltd., identified during an FDA manufacturing inspection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 source text is classified as FDA Class II and specifies only generic "quality issues" without identifying a specific hazard, mechanism of harm, or any reported illnesses or injuries. No concrete adverse health consequences are stated or implied, making this a voluntary precautionary recall that merits a Moderate score.
Plain-English summary
Medline Industries, LP is recalling three arterial access and insertion kits distributed nationwide. The affected products are: (1) Arterial Access Tray with Lidocaine, Model ART1145, Lot Numbers 2025120590 and 2025101490; (2) Universal Central/Arterial Line Insertion Kit, Model ART155A, Lot Number 2025100890; and (3) Arterial Line Insertion Tray, Model ART1010B, Lot Number 2025091590. The total quantity affected is 5,698 kits.
The kits contain Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules, which are subject to a recall by Huons Co., Ltd., the ampule manufacturer. The recall was initiated due to quality issues identified during an FDA manufacturing inspection of Huons' drug manufacturing facility.
Consumers and healthcare providers who have these kits should contact Medline Industries for further instructions. The source does not specify what action to take with the kits or whether they should be returned.
The recalled product
- Product
- 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
- Manufacturer
- Medline Industries, LP
- Hazard
- Affected units
- 5,698
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 (14)
- 1) ART1145
- UDI-DI: 10653160349259(each)
- 00653160349252(case)
- Lot Number: 2025120590
- 2) ART1145
- Lot Number: 2025101490
- 3) ART155A
- UDI-DI: 10653160316459(each)
- 00653160316452(case)
- Lot Number: 2025100890
- 4) ART1010B
- UDI-DI: 10653160353577(each)
- 00653160353570(case)
- Lot Number: 2025091590
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 15 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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