FDA-Device2026-07-08Class IIPROCESSING DEFECT
Medline Convenience Suturing Set recalled for Lidocaine quality defect
What this means
Medline Convenience Kits (Model SUT13710) contain Lidocaine Ampules that were subject to a recall by the manufacturer Huons Co., Ltd. due to quality issues found during an FDA inspection of their manufacturing facility. About 176 kits were distributed nationwide.
- Check if you have Medline Convenience Suturing Set Model SUT13710 with Lot Number 2025102290.
- Contact Medline Industries for instructions on returning or disposing of the affected kits.
- Do not use the kits until you confirm whether your lot is affected.
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
176 kits
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline Convenience Kits: 1) SUTURING SET, Model Number: SUT13710
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2540-2026More Medline recalls
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