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: HEMODIALYSIS KIT: 2-LUMEN 8 FR X 11 CM/AK-11802-F; HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-22122; HEMODIALYSIS KIT 2L: 14 FR X 15CM AGB/AK-22142-CDC; HEMODIALYSIS KIT 2L: 14 FR X 20CM AGB/AK-25142-CDC; HEMODIALYSIS KIT: 2L 14 FR X 15 CM/ASK-22142-UMD; HEMODIALYSIS KIT: 2L 14 FR X 15 CM/ASK-22142-UNC; HEMODIALYSIS KIT: 2L 14 FR X 20 CM/ASK-25142-UMD; HEMODIALYSIS KIT 2L: 14 FR X 20 CM AGB/ASK-25142-UN1; HEMODIALYSIS KIT: 2L 14 FR X 25 CM/ASK-26142-UMD; HEMODIALYSIS KIT: 2LUMEN 12 FR X 13 CM/AU-23122-F; HEMODIALYSIS KIT: 2LUMEN 12 FR X 20 CM/AU-25122-F; HEMODIALYSIS KIT: 2L 12 FR X 16 CM AGB/CDC-22122-X1A; HEMODIALYSIS KIT: 2L 12 FR X 16 CM AGB/CDC-22122-XU1A; HEMODIALYSIS KIT: 2L 14 FR X 15 CM AGB/CDC-22142-X1A; HEMODIALYSIS KIT: 2L 12 FR X 25 CM AGB/CDC-26122-X1A; HEMODIALYSIS KIT 2L: 12 FR X 16CM AGB/AK-22122-CDC; HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-22122-F; HEMODIALYSIS KIT: 2-LUMEN 14 FR X 15 CM/AK-22142-F; AHDC AGB U-BEND KIT: 2-L 12 FR X 16 CM/CDC-22122-CN1AU; AHDC AGB CURVED KIT: 2-L 14 FR X 15 CM/CDC-22142-CN1AC; AHDC AGB U-BEND KIT: 2-L 12 FR X 13 CM/CDC-23122-CN1AU; AHDC AGB U-BEND KIT: 2-L 12 FR X 20 CM/CDC-25122-CN1AU; AHDC AGB CURVED KIT: 2-L 14 FR X 20 CM/CDC-25142-CN1AC;
REF(Material)/UDI-DI/Lot(Batch): AK-11802-F/10801902193275, 10801902197129/33F24G0344, 33F24J0511, 33F24L0637, 33F25A0473, 33F25E0060, 33F25J0473, 33F24A0848; AK-22122/10801902193275/33F24H0232, 33F24J0523; AK-22142-CDC/10801902193275/33F24J0527, 33F24K0129, 33F24L0649, 33F25C0115, 33F25C0959, 33F25E0940, 33F25J0481, 33F25L0428, 33F24G0364; AK-25142-CDC/10801902193275, 50801902123195/33F25A0486, 33F25C0892, 33F25E0086, 33F25E0944, 33F25J0485, 33F25J0845, 33F25L0374, 33F26B0521, 33F25A0487; ASK-22142-UMD/10801902193275, 10801902136470, 10801902143690/33F25F0362, 33F25J0094, 33F26A0244, 33F26B0137, 33F24F0041; ASK-22142-UNC/10801902193275/33F25G0269, 33F24K0560; ASK-25142-UMD/10801902193275, 10801902136500/33F25B0239, 33F25E0308, 33F25G0686, 33F25K0425, 33F26A0246, 33F26C0047, 33F24K0696; ASK-25142-UN1/10801902193275, 10801902156379/33F24L1157, 33F26B0908, 33F25B0420; ASK-26142-UMD/10801902193275, 33F26A0408, 33F25B0427; AU-23122-F/10801902193275/33F25C0877, 33F25H0157, 33F24L0038; AU-25122-F/10801902193275, 70801902123328, 10801902210071/33F25G0562, 33R24L0038, 33F24D0400; CDC-22122-X1A/10801902193275, 10801902213478/33F25E0694, 33F25G0268, 33F24D0693; CDC-22122-XU1A/10801902193275, 10801902168044/33F25E0652, 33F25H0643, 33F24D0830; CDC-22142-X1A/10801902193275/33F25A0284; CDC-26122-X1A/10801902213515/33F24F1028; AK-22122-CDC/10801902193275, 10801902198492/33F24K0125, 33F24L0647, 33F25C0114, 33F25E0936, 33F25G0091, 33F24E0355; AK-22122-F/10801902193275/33F24G0360, 33F24J0524, 33F24K0126, 33F25A0482, 33F25E0075, 33F25E0937, 33F25J0839, 33F25L0413, 33F24G0361; AK-22142-F/10801902193275/33F24L0662, 33F25C0117, 33F25C0865, 33F25H0034, 33F25J0841, 33F24K0130; CDC-22122-CN1AU/10801902193275, 10801902222265/33F26A1388, 33F26B0398, 33F24L0966; CDC-22142-CN1AC/10801902193275/33F26A1550, 33F25J0455; CDC-23122-CN1AU/10801902193275, 10801902222319/33F26A0008, 33F26A1478, 33F26B0397, 33F24L0279; CDC-25122-CN1AU/10801902193275/33F25M0346, 33F25E0882; CDC-25142-CN1AC/30801902123597/36F25B0018
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.