Medline L&D Continuous Epidural Tray Kits Recalled for Quality Issues
Medline Industries is recalling 432 L&D Continuous Epidural Tray kits nationwide due to quality issues identified with the included Lidocaine ampules during an FDA manufacturing inspection.
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: FDA Class II recall with no reported illnesses or injuries. The hazard is described generically as "quality issues" without specification of harm potential, and no adverse health consequences have been reported.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience Kits containing L&D Continuous Epidural Trays (Model Number: PAIN1699A, UDI-DI: 10195327411107 and 40195327411108, Lot Number: 25JLA719). The kits contain Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules, which were recalled by Huons Co., Ltd. due to quality issues identified during a recent FDA manufacturing inspection of Huons' drug manufacturing site.
A total of 432 kits have been distributed nationwide in the United States. The recall affects the specific lot number noted above. Patients and healthcare providers who have received these kits should consult with their healthcare provider regarding the appropriate course of action.
The recalled product
- Product
- Medline Convenience Kits: 1) L&D CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1699A
- Manufacturer
- Medline Industries, LP
- Affected units
- 432
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) PAIN1699A
- UDI-DI: 10195327411107(each)
- 40195327411108(case)
- Lot Number: 25JLA719
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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