Medline Convenience Kits Block Tray recalled due to quality defects
Medline Industries is recalling Convenience Kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules due to quality issues identified during an FDA manufacturing inspection of the 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: The recall is classified as FDA Class II and involves quality defects identified during manufacturing inspection. No reported illnesses or injuries are mentioned in the source text, making this a precautionary quality-based recall rather than a direct patient-safety incident.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience Kits that contain Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules. The recall was initiated based on quality issues identified during a recent FDA manufacturing inspection of Huons Co., Ltd.'s drug manufacturing site.
The affected kit is Model Number DYNJRA1590 (Lot Number 25JLA522). A total of 270 kits were distributed nationwide across the United States. The product can be identified by UDI-DI 10193489284829 (each) or 40193489284820 (case).
Patients and healthcare providers who have received or dispensed these kits should discontinue use and contact Medline Industries, LP for instructions on returning or disposing of the product. Patients currently using the Lidocaine Ampules should consult their healthcare provider for alternative treatment options.
The recalled product
- Product
- Medline Convenience Kits: 1) BLOCK TRAY, Model Number: DYNJRA1590
- Manufacturer
- Medline Industries, LP
- Category
- Drug — Injectable Anesthetic
- Affected units
- 270
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 (4)
- 1) DYNJRA1590
- UDI-DI: 10193489284829(each)
- 40193489284820(case)
- Lot Number: 25JLA522
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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