Consumer Alerts Tracker
openFDA Medical device

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

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.

Official details

Category
Medical device recall
Status
Ongoing
Classification
Class II
Company or vendor
Medline Industries, LP
Affected product
US Nationwide distribution.
Risk or reason
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.
Remedy or action
1) SUT13710, UDI-DI: 00653160148527(each), 10653160148524(case), Lot Number: 2025102290
Official ID
Z-2540-2026