Medline Convenience Kits with Lidocaine Ampules Recalled for Quality Issues
Medline Industries is recalling three convenience kits containing Huons Lidocaine HCL Injection USP 1% due to quality issues identified during an FDA manufacturing inspection of Huons' 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 source identifies quality issues from an FDA manufacturing inspection but does not specify the nature of the defect, report any illnesses, injuries, or deaths, or provide an FDA classification for the recall. The recall is precautionary based on manufacturing inspection findings.
Plain-English summary
Medline Industries, LP is recalling three models of convenience kits that contain Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules. The recall affects Model Numbers SM RADIOLOGY-ANGIO PACK-LF (DYNJ0621189X), CONT. 20G EPI MRI COMPATIBLE (PAIN1470A), and TVS4000 ENDOVENOUS PACK (TVS4000L). A total of 333 kits have been distributed nationwide in the United States.
The kits are being recalled due to quality issues identified during a recent FDA manufacturing inspection of Huons Co., Ltd.'s drug manufacturing facility. Specific details about the nature of the quality issues are not provided in this notice.
Consumers or healthcare providers who have these kits should not use them and should contact Medline Industries, LP for instructions on return or replacement.
The recalled product
- Product
- Medline Convenience Kits: 1) DYNJ0621189X, Model Number: SM RADIOLOGY-ANGIO PACK-LF; 2) PAIN1470A, Model Number: CONT. 20G EPI MRI COMPATIBLE; 3) TVS4000L, Model Number: TVS4000 ENDOVENOUS PACK
- Manufacturer
- Medline Industries, LP
- Hazard
- Affected units
- 333
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 (16)
- 1) DYNJ0621189X
- UDI-DI: 10195327638566(each)
- 40195327638567(case)
- Lot Number: 25ILA890
- 2) PAIN1470A
- UDI-DI: 10193489957365(each)
- 40193489957366(case)
- Lot Number: 25JLA514
- 3) TVS4000L
- UDI-DI: 10195327223540(each)
- 40195327223541(case)
- Lot Number: 25JDB583
- 4) TVS4000L
- Lot Number: 25KDA180
- 5) TVS4000L
- Lot Number: 25KDB274
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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