FDA-Device2026-07-08Class IIPROCESSING DEFECT
Medline Lumbar Puncture Choice Kit recalled for Lidocaine quality issues
What this means
Medline's Lumbar Puncture Choice Kit (Model DYNDH1215) contains Lidocaine Ampules manufactured by Huons Co., Ltd. that have quality issues identified during an FDA inspection of the manufacturer's facility. The affected kits were distributed nationwide.
- If you have this kit, stop using it and contact Medline or your healthcare provider.
- Check your kit's lot number (2025092390) against the recall notice.
- Return the kit to your supplier or contact Medline for instructions.
The agency's original wording
Hazard
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
420 kits
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline Convenience Kits: 1) LUMBAR PUNCTURE CHOICE, Model Number: DYNDH1215
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2544-2026More Medline recalls
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