Medline Convenience Kits with Lidocaine Ampules Recalled for Quality Issues
Medline Industries is recalling Medline Convenience Kits containing Huons Lidocaine HCL Injection USP 1% due to quality issues identified during an FDA manufacturing 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 classified as FDA Class II (per agency designation), and the source text does not report any illnesses or injuries. The hazard involves "quality issues" that are not explicitly detailed as high-risk pathogenic contamination or structural failure, making this a moderate precautionary recall without reported adverse health consequences.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience Kits that contain Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules. The kits affected are: 1) STD, INTRO-FLEX INTRODUCER 6F, C, Model Number I550BF6C, Lot Number 2025102290; and 2) STD, INTRO-FLEX INTRODUCER 9F, C, Model Number I505BF9C, Lot Number 2025093090.
The recall was initiated due to quality issues identified during a recent FDA manufacturing inspection of Huons Co., Ltd.'s drug manufacturing site.
Approximately 510 kits were distributed nationwide in the United States. Consumers and healthcare facilities who have received these kits should discontinue use and contact Medline Industries, LP for further instructions regarding the return or destruction of the affected products.
The recalled product
- Product
- Medline Convenience Kits: 1) STD, INTRO-FLEX INTRODUCER 6F, C, Model Number: I550BF6C; 2) STD, INTRO-FLEX INTRODUCER 9F, C, Model Number: I505BF9C
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Injection Kit
- Hazard
- Affected units
- 510
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) I550BF6C
- UDI-DI: 10653160339748(each)
- 00653160339741(case)
- Lot Number: 2025102290
- 2) I505BF9C
- UDI-DI: 10653160339687(each)
- 00653160339680(case)
- Lot Number: 2025093090
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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