Medline Industries, LP: Medline Convenience Kits: 1) DYNJ0621189X, Model Number: SM RADIOLOGY-ANGIO PACK-LF; 2) PAIN1470A, Model Number: CONT. 20G EPI MRI COMPATIBLE; 3) TVS4000L, Model Number: TVS400

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: 333 kits Lot/code info: 1) DYNJ0621189X, UDI-DI: 10195327638566(each), 40195327638567(case), Lot Number: 25ILA890; 2) PAIN1470A, UDI-DI: 10193489957365(each), 40193489957366(case), Lot Number: 25JLA514; 3) TVS4000L, UDI-DI: 10195327223540(each), 40195327223541(case), Lot Number: 25JDB583; 4) TVS4000L, UDI-DI: 10195327223540(each), 40195327223541(case), Lot Number: 25KDA180; 5) TVS4000L, UDI-DI: 10195327223540(each), 40195327223541(case), Lot Number: 25KDB274

UPC codes

10195327638566, 40195327638567, 10193489957365, 40193489957366, 10195327223540, 40195327223541

Source

Official record: FDA (Device enforcement) ↗

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