Medline Convenience Kits recalled for defective Lidocaine Ampules
Medline Industries is recalling 15,662 Convenience Kits containing Huons Lidocaine HCL Injection USP due to quality issues identified during an FDA manufacturing inspection of the drug supplier's facility.
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: This is an FDA Class II recall. The source text does not report any illnesses, injuries, or deaths, and the quality issues are identified but not specified as creating an imminent health risk. The recall is precautionary in nature based on inspection findings.
Plain-English summary
Medline Industries, LP is recalling 15,662 Convenience Kits distributed nationwide that contain Huons Lidocaine HCL Injection USP 1% 10mg/ml in 5mL Ampules. The recall was initiated following quality issues identified during an FDA manufacturing inspection of Huons Co., Ltd.'s drug manufacturing site.
The affected kits include multiple models used for medical procedures, including suture trays, chest tube insertion trays, contraceptive implant insertion kits, radial and femoral arterial line kits, myelogram packs, laceration trays, biopsy trays, incision and drainage trays, and related surgical kits. Specific lot numbers and UDI codes for each kit model are available from the FDA.
Patients and healthcare providers who have received or are using these kits should contact Medline Industries for instructions on how to proceed. Healthcare facilities should verify whether they have received any of the recalled kits and take appropriate action to ensure patient safety.
The recalled product
- Product
- Medline Convenience Kits: 1) SUTURE TRAY, Model Number: SUT12260; 2) CHEST TUBE INSERTION TRAY, Model Number: MNS3390; 3) CONTRACEPTIVE IMPLANT INSERTION KIT, Model Number: MNS9715; 4) 20GX3" RADIAL ART LINE KIT, Model Number: ART351; 5) MYELOGRAM PACK, Model Number…
- Manufacturer
- Medline Industries, LP
- Affected units
- 15,662
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 (20)
- 1) SUT12260
- UDI-DI: 00653160130942(each)
- 10653160130949(case)
- Lot Number: 2026031190
- 2) MNS3390
- UDI-DI: 00653160100433(each)
- 10653160100430(case)
- Lot Number: 2025120590
- 3) MNS9715
- UDI-DI: 10653160292029(each)
- 00653160292022(case)
- Lot Number: 2025120890
- 4) ART351
- UDI-DI: 10653160323754(each)
- 00653160323757(case)
- Lot Number: 2025120990
- 5) P155615A
- UDI-DI: 10889942219889(each)
- 40889942219880(case)
- 6) MNS3390
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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