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.
Description/REF: AGBA PICC G4 Stylet: 3L 6FR x 55CM BP/DLX-45563-VPSB; AGBA PICC G4 Stylet: 3L 6FR x 55CM TCG/DLX-45563-VPSC; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-UCHD1; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-UCHS1; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-DU13; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-UNHS1
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
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.