Medline Convenience Kits with Lidocaine Ampules Recalled for Quality Issues
Medline Industries is recalling 1,512 Convenience Kits nationwide that contain Lidocaine HCL Injection USP 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 FDA classified this as a Class II recall. The source text does not report any illnesses, injuries, or adverse events; the hazard is a quality issue identified during inspection, making this a precautionary recall without reported patient harm.
Plain-English summary
Medline Industries, LP is recalling ten models of Convenience Kits distributed nationwide. The kits contain Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules), an over-the-counter medication supplied by Huons Co., Ltd. The recall was initiated after the FDA identified quality issues during a recent manufacturing inspection of Huons' drug manufacturing site.
Affected models include PAIN0072L, PAIN1317, PAIN1579A, PAIN1885A, PAIN1967A, PAIN2269, PAIN2278, PAIN2305, PAIN2334, and SAMPA0147. A total of 1,512 kits have been distributed. Patients and healthcare providers in receipt of these kits should discontinue use and contact Medline Industries for instructions on return or replacement of the affected products.
The recalled product
- Product
- Medline Convenience Kits: 1) PAIN MGMT/ PREF W. MED NDL, Model Number: PAIN0072L; 2) CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1317; 3) CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1579A; 4) CSE TRAY, Model Number: PAIN1885A; 5) REINFORCED CATH EPIDURAL TRAY, Model Number…
- Manufacturer
- Medline Industries, LP
- Hazard
- Affected units
- 1,512
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) PAIN0072L
- UDI-DI: 10198459544163(each)
- 40198459544164(case)
- Lot Number: 25JDB100
- 2) PAIN1317
- UDI-DI: 10888277797109(each)
- 40888277797100(case)
- Lot Number: 25JLA788
- 3) PAIN1579A
- UDI-DI: 10193489422443(each)
- 40193489422444(case)
- Lot Number: 25JLA779
- 4) PAIN1885A
- UDI-DI: 10195327486310(each)
- 40195327486311(case)
- Lot Number: 25JLA861
- 5) PAIN1967A
- UDI-DI: 10198459241215(each)
- 40198459241216(case)
- Lot Number: 25JLA659
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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