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.
Medline Convenience Kits: 1) ARTERIAL ACCESS TRAY W/LIDOCAINE, Model Number: ART1145; 2) Universal Central/Art Line Insertion Kit, Model Number: ART155A; 3) ARTERIAL LINE INSERTION TRAY, Model Number: ART1010B
1) ART1145, UDI-DI: 10653160349259(each), 00653160349252(case), Lot Number: 2025120590; 2) ART1145, UDI-DI: 10653160349259(each), 00653160349252(case), Lot Number: 2025101490; 3) ART155A, UDI-DI: 10653160316459(each), 00653160316452(case), Lot Number: 2025100890; 4) ART1010B, UDI-DI: 10653160353577(each), 00653160353570(case), Lot Number: 2025091590
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.