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.
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: 11,358 Lot/code info: REF(Material)/UDI-DI/Lot(Batch): DLX-45563-VPSB/10801902193275/33F25C0704, 33F25D0316, 33F25D0627, 33F25M0094, 33F24L0860; DLX-45563-VPSC/10801902193275, 10801902208658, 10801902210118/33F25B0509, 33F25C0340, 33F25D0255, 33F25D0628, 33F25E0767, 33F25E0901, 33F25F0227, 33F25J0448, 33F25K0036, 33F26C0104, 33F26C0107, 33F24C0257; ASK-04001-UCHD1/10801902193275, 10801902219005/33F25H0415, 33F25J0349, 33F26B0440, 33F24L0396; ASK-04001-UCHS1/10801902193275, 10801902219067/33F24L1083, 33F25D0331, 33F25E0521, 33F25E0846, 33F25K0068, 33F25K0107, 33F25M0133, 33F26A1417, 33F26C0029, 33F24K0406; ASK-04001-DU13/10801902193275, 10801902201970/33F25B0514, 33F25C0703, 33F25F0090, 33F25F0124, 33F25H0421, 33F25J0197, 33F26A1372, 33F26B0850, 33F26C0369, 33R25A0227, 33F24K0314; ASK-04001-UNHS1/10801902193275, 10801902211887, 10801902158854/33F25A0229, 33F25C0714, 33F25D0390, 33F25E0847, 33F25G0244, 33F25M0129, 33F26A1139, 33F26C0370, 33F24E0400
10801902193275, 10801902208658, 10801902210118, 10801902219005, 10801902219067, 10801902201970, 10801902211887, 10801902158854
Official record: FDA (Device enforcement) ↗
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