ARROW INTERNATIONAL, LLC: Description/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-X1ASP ACCESS TRAY/ASK-04001-MS RA CATH KIT: 20 GA X 8 CM/ASK-00820-UM1

Hazard

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Details from the source

Reason for recall: Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries. Distribution: US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR. Quantity: 126,530 Lot/code info: REF(Material)/UDI-DI/Lot(Batch): ASK-04510-MM6/10801902193275, 10801902221909/33F25E0590, 33F25G0196, 33F25M0005, 33F25M0149, 33F26A0302, 33F26C0723, 33F24K0212; NA-04020-X1ASP/10801902193275/33F25J0575, 33F25J0756, 33F26B0065, 33F26B0027; ASK-04001-MS/10801902193275/33F24K0706, 33F25F0375, 33F25F0005; ASK-00820-UM1/10801902193275/33F24G0150; AK-04550-S/10801902196719, 10801902193275, 60801902121709/33F24A0029, 33F24A0355, 33F24A1014, 33F24A1619, 33F24B0112, 33F24C0548, 33F24D0017, 33F24E0174, 33F24G0328, 33F24G0576, 33F24J0276, 33F24J0494, 33F24K0092, 33F24L0720, 33F25A0458, 33F25C0950 33F25E0041, 33F25E0911, 33F25G0080, 33F25H0013, 33F25J0820, 33F25L0402, 33F26B0550, 33F26C0267, 33F23M0175; AK-04301-SP/10801902121650, 10801902193275, 10801902121674/33F24A1010, 33F24C0093, 33F24D0068, 33F24E0325, 33F24G0325, 33F24J0274, 33F24K0090, 33F24L0809, 33F25C0757, 33F25E0038, 33F25G0760, 33F25H0721, 33F25J0462, 33F25L0239, 33F25M0888, 33F24A0146; AK-04306-SP/10801902121674, 10801902193275, 10801902192230/33F24A0846, 33F24B0174, 33F24C0094, 33F24E0327, 33F24E0329, 33F24J0275, 33F24J0492, 33F24L0717, 33F25B0249, 33F25C0783, 33F25E0039, 33F25J0463, 33F25L0054, 33F25L0345, 33F26B0684, 33F23J0175; AK-04800-S/60801902121709, 10801902193275, 10801902209501/33F24B0437, 33F24C0735, 33F24E0708, 33F24G0120, 33F24G0647, 33F24H0415, 33F24J0448, 33F24L0037, 33F24M0128, 33F25A0396, 33F25B0111, 33F25D0028, 33F25G0509, 33F25H0326, 33F25J0997, 33F26C0274, 33F24C0013; AK-12402/10801902168471, 108019021

UPC codes

10801902193275, 10801902221909, 10801902196719, 60801902121709, 10801902121650, 10801902121674, 10801902192230, 10801902209501, 10801902168471, 10801902168488, 10801902168495, 10801902168518, 30801902122040, 10801902122077, 10801902197136, 10801902168532, 10801902168549, 10801902168563, 10801902168570, 30801902122248, 20801902114987, 10801902115260

Source

Official record: FDA (Device enforcement) ↗

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