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

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.

Details from the source

Reason for recall: 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. Distribution: US Nationwide distribution. Quantity: 176 kits Lot/code info: 1) SUT13710, UDI-DI: 00653160148527(each), 10653160148524(case), Lot Number: 2025102290

UPC codes

00653160148527, 10653160148524

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.