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: PI JACC KIT: 2L 5.5 FR X 15 CM CG+/ASK-41552-LTAC; PI JACC KIT: 3L 6 FR X 20 CM CG+/ASK-42063-LTAC; AGBA PI JACC KIT: 1-L 4.5 FR X 15 CM/CDC-41541-JX1A; AGBA PI JACC KIT: 2-L 5.5 FR X 15 CM/CDC-41552-JX1A; AGBA PI JACC KIT: 3-L 6 FR X 15 CM/CDC-41563-JX1A; AGBA PI JACC KIT: 1-L 4.5 FR X 20 CM/CDC-42041-JX1A; AGBA PI JACC KIT: 2-L 5.5 FR X 20 CM/CDC-42052-JX1A; AGBA PI JACC KIT: 3-L 6 FR X 20 CM/CDC-42063-JX1A
REF(Material)/UDI-DI/Lot(Batch): ASK-41552-LTAC/10801902193275/33F24J0142, 33F24H0002; ASK-42063-LTAC/10801902214925/33F24F1005; CDC-41541-JX1A/10801902193275/33F25H0768; CDC-41552-JX1A/10801902193275, 10801902201505/33F25A0185, 33F25E0826, 33F24D0561; CDC-41563-JX1A/10801902193275/33F25B0150; CDC-42041-JX1A/10801902193275, 10801902188288/33F25E0751, 33F26C0353, 33F25A0186; CDC-42052-JX1A/10801902193275/33F25G0312, 33F24J0131; CDC-42063-JX1A/10801902193275/33F25C0447, 33F25D0516, 33F25E0752, 33F25J0436, 33F25C0370
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.