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Medline Industries, LP: Medline Convenience Kits: 1) SUTURING SET, Model Number: SUT13710

Medical DevicesSource: FDA (device) · Date: 2026-07-08

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Medline Industries, LP
Product
Medline Convenience Kits: 1) SUTURING SET, Model Number: SUT13710
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution.
Recall initiated
2026-05-21
Code info
1) SUT13710, UDI-DI: 00653160148527(each), 10653160148524(case), Lot Number: 2025102290
Product quantity
176 kits
Voluntary mandated
Voluntary: Firm initiated
City
Northfield
State
IL
Country
United States
Event id
99162
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