Z-2397-2026 Class I Ongoing

Description/REF: RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-1A; RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-X1A; ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018-HCA; ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018-UPM; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-HC; ARTERIAL LINE KIT: 20 GA X 5IN (12 CM)/ASK-04020-HMC; RADIAL ARTERY CATHETER KIT: 20 GA X 30MM/ASK-04020-MMC; RA CATH KIT: 20 GA X 1-1/2IN (3.81 CM)/ASK-04020-SV; ARTERIAL CATH KIT: 20 GA X 5 IN (12 CM)/ASK-04100-AMC-S1; ARTERIAL CATHETER KIT: 20 GA X 12 CM/ASK-04100-NS; RADIAL ARTERY KIT/ASK-04500-AH; RAD ART:20GAX3.81CM / ART LINE:20GAX12CM/ASK-04500-HF-S; ARTERIAL LINE KIT: 1L 20 GA X 12 CM/ASK-04510-HA; ARTERIAL LINE KIT: 20 GA. X 5 IN (12 CM)/ASK-04510-HF; ARTERIAL LINE KIT: 20 GA X 5 IN (12 CM)/ASK-04510-IHC1; ARTERIAL LINE KIT: 20 GA X 5 IN (12 CM)/ASK-04510-MSK2; ARTERIAL CATH KIT: 20GA X 5IN/ASK-04510-NS; ARTERIAL CATHETER KIT: 20 GA X 12 CM/FS-04510-S; ARTERIAL LINE KIT/HF-04510-1; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-BSM; RA CATH KIT: 20 GA X 1 3/4 IN (4.45CM)/ASK-04020-HH1; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-JMH1; RA CATH KIT: 20 GA X 1-3/4 IN/ASK-04020-MAS; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-MCC; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MHT; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MI; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-MIHS; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MUSC; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-NCB; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-PMC; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-SPH; RA CATH SET: 20 GA X 1-3/4IN (4.45CM)/ASK-04020-UPM; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-UR1; RA CATH KIT: 20 GA X 4.45 CM/NA-04020-X1A; RA CATH KIT: 20 GA X 1-3/4IN/WBH-04020-1; CVC KIT: 20 GA X 12CM/ASK-04510-UCLA; ARTERIAL ACCESS TRAY WITH .025IN SWG/ASK-04001-BW1

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.

REF(Material)/UDI-DI/Lot(Batch): NA-04220-1A/10801902193275/33F26B0027; NA-04220-X1A/10801902193275/33F24G0553, 33F25E0272, 33F25E1053, 33F25H0760, 33F25J0636; ASK-04018-HCA/10801902119268/33F24A0078; ASK-04018-UPM/50801902117644, 10801902193275/33F23B0953, 33F24A0389, 33F24B0140, 33F24D0028, 33F24H0480, 33F24J0550, 33F24K0164, 33F25A0505, 33F25C0742, 33F25C0792, 33F25E0961, 33F25E1070, 33F25E1071, 33F25E1072, 33F25G0105, 33F25H0062, 33F25J0866, 33F25L0353, 33F26B0507; ASK-04020-HC/10801902121384, 10801902193275/33F24A0828, 33F24B0246, 33F24C0148, 33F24D0113, 33F24G0409, 33F24J0559, 33F24K0172, 33F24L0693, 33F25C0136, 33F25C0933, 33F25E0128, 33F25H0070, 33F25L0356; ASK-04020-HMC/10801902117691, 10801902193275/33F24A0324, 33F24A0743, 33F24B0248, 33F24C0150, 33F24D0115, 33F24H0475, 33F24K0174, 33F24L0802, 33F25H0072, 33F25J0872, 33F25L0395, 33F26B0650, 33S24A0743, 33S24C0150, 33F26B0673; ASK-04020-MMC/10801902117769, 10801902193275/33F24C0160, 33F24D0123, 33F24E0423, 33F24G0420, 33F24H0487, 33F24J0571, 33F24K0183, 33F24L0692, 33F25A0523, 33F25C0974, 33F25E0139, 33F25H0081, 33F25J0880, 33F25L0346, 33F25M0853; ASK-04020-SV/10801902117837, 10801902117837/33F24A0868, 33F24B0269, 33F24E0436, 33F24E0437, 33F24L0746, 33F25H0087, 33F25J0885, 33F26B0512; ASK-04100-AMC-S1/10801902124927, 10801902193275/33F24D0139, 33F24E0446, 33F24G0439, 33F24K0199, 33F25A0532, 33F25E0153, 33F25G0116, 33F25H0093, 33F25J0516, 33F26B0656; ASK-04100-NS/10801902193275, 10801902117929/33F24G0440, 33F24L0579, 33F24M0266, 33F25A0533, 33F25C0151, 33F25C0788, 33F25E0155, 33F25H0095, 33F25J0518, 33F25K0256, 33F25L0448, 33F25M0945, 33F26B0649, 33F26B0667; ASK-04500-AH/10801902114041, 10801902193275/33F24A0153, 33F24A0803, 33F24B0282, 33F24C0181, 33F24E0452, 33F24G0444, 33F24J0586, 33F25A0538, 33F25H0101, 33F25J0893; ASK-04500-HF-S/10801902118001, 10801902193275/33F24A0141, 33F24A0753, 33F24A1157, 33F24B0283, 33F24C0182, 33F24D0143, 33F24E0453, 33F24G0445, 33F24J0587, 33F24K0206, 33F24L0766, 33F25C0154, 33F25C0966, 33F25E0161, 33F25H0102, 33F25J0894, 33F25L0492, 33R25C0966; ASK-04510-HA/10801902193275/33F24J0591, 33F24K0210, 33F25B0685, 33F25C0911, 33F25E0166, 33F25E0993, 33F25J0524, 33F25L0449; ASK-04510-HF/10801902193275, 10801902118025/33F24G0450, 33F24J0305, 33F24K0211, 33F24L0543, 33F24L0558, 33F25A0540, 33F25C0896, 33F25E0167, 33F25G0119, 33F25H0104, 33F25J0525, 33F25K0412, 33F25L0339, 33F26B0648, 33F26B0666, 33F26C0588; ASK-04510-IHC1/10801902193275/33F24J0306, 33F24L0699, 33F25C0157, 33F25C0782, 33F25E0168, 33F25H0105, 33F25L0475; ASK-04510-MSK2/10801902118049, 10801902193275/33F24A0872, 33F24B0290, 33F24D0150, 33F24E0461, 33F24G0453, 33F24J0594, 33F25A0541, 33F25C0852, 33F25E0170, 33F25H0740; ASK-04510-NS/10801902193275, 10801902224177/33F25K0324, 33F26B0653; FS-04510-S/10801902193275, 10801902119824/33F24L0738, 33F25C0188, 33F25C0755, 33F25L0426, 33F26B0657; HF-04510-1/10801902119855, 10801902193275/33F24D0036, 33F24G0537, 33F24J0652, 33F24L0576, 33F25A0593, 33F25C0897, 33F25E0260, 33F25E1044, 33F25H0166, 33F25J0936, 33F26B0652, 33F26B0675; ASK-04020-BSM/10801902193275/33F24J0365, 33F24M0075, 33F25A0079, 33F25B0312, 33F25D0116, 33F25D0297, 33F25E0367, 33F25F0400, 33F25G0653, 33F25J0983, 33F25L0155; ASK-04020-HH1/10801902193275, 10801902128536/33F24K0173, 33F24L0729, 33F25C0137, 33F25C0914, 33F25E0129, 33F25H0071, 33F25J0871, 33F25L0420, 33F26B0563; ASK-04020-JMH1/10801902114089, 10801902193275/33F24A0792, 33F24C0152, 33F24D0117, 33F24E0416, 33F24H0481, 33F24J0562, 33F24L0775, 33F25A0515, 33F25C0139, 33F25C0970, 33F25E0975, 33F25H0074, 33F25J0875, 33F25L0330, 33F26A0969; ASK-04020-MAS/10801902193275/33F25K0032; ASK-04020-MCC/10801902193275/33F24K0063, 33F24M0043; ASK-04020-MHT/10801902117721, 10801902193275/33F24A0094, 33F24B0019, 33F24D0052, 33F24D0966, 33F24J0475, 33F24L0083, 33F25C0739, 33F25E0980, 33F25F0529, 33F25J0506, 33F25K0329, 33F26A0403, 33F26C0056, 33F26C0260; ASK-04020-MI/10801902193275/33F24K0549, 33F25A0521, 33F25E1149, 33F25F0453, 33F25G0679, 33F25H0079, 33F25H0734, 33F25J0794, 33F25K0327, 33F25L0207, 33F25M0689, 33F26A0398; ASK-04020-MIHS/10801902193275/33F25A0442, 33F25B0233, 33F25C0379, 33F25D0035, 33F25H0494, 33F25K0426; ASK-04020-MUSC/10801902117776, 10801902193275/33F24A0751, 33F24A1138, 33F24B0259, 33F24C0162, 33F24D0125, 33F24E0425, 33F24G0421, 33F24K0184, 33F24L0640, 33F25C0141, 33F25C0830, 33F25E0140, 33F25H0083, 33F25J0881, 33F26B0575; ASK-04020-NCB/10801902117783, 10801902193275/33F24A0864, 33F24B0260, 33F24C0163, 33F24E0426, 33F24G0422, 33F24J0572, 33F24K0185, 33F24L0711, 33F25C0921, 33F25E0141, 33F25H0084, 33F25J0508, 33F25M0857; ASK-04020-PMC/30801902158896, 10801902193275/33F24F0095, 33F24L0242; ASK-04020-SPH/10801902193275/33F25C0143, 33F25C0977, 33F25E0985, 33F25H0735, 33F26A1075; ASK-04020-UPM/10801902117851, 10801902193275/33F24A0255, 33F24A0385, 33F24A1037, 33F24B0141, 33F24C0033, 33F24E0095, 33F24G0434, 33F24J0299, 33F24K0195, 33F24L0578, 33F25A0529, 33F25C0147, 33F25C0898, 33F25E0149, 33F25H0090, 33F25J0886, 33F25L0405, 33F26B0553; ASK-04020-UR1/10801902193275/33F24K0196, 33F24L0748, 33F25C0148, 33F25C0850, 33F25E0150, 33F25G0114, 33F25L0460, 33F25M0953; NA-04020-X1A/10801902193275, 30801902119927/33F24J0683, 33F24K0295, 33F24L0575, 33F24L0784, 33F25A0601, 33F25A0622, 33F25C0951, 33F25E0271, 33F25E1051, 33F25G0153, 33F25H0178, 33F25J0634, 33F25J0941, 33F25K0322, 33F25K0323, 33F25L0327, 33F25M0837, 33F26B0491; WBH-04020-1/10801902162943, 10801902193275/33F24B0465, 33F24C0787, 33F24E0780, 33F24G0659, 33F24J0435, 33F25A0124, 33F25B0054, 33F25B0110, 33F25B0227, 33F25C0404, 33F25C0522, 33F25E1163, 33F25G0630, 33F25H0349, 33F25J0080, 33F25L0162, 33F26B0060, 33F26C0408; ASK-04510-UCLA/10801902118070, 10801902193275/33F24C0189, 33F24E0465, 33F24G0455, 33F24K0215, 33F25A0543, 33F25C0861, 33F25E0173, 33F25H0106, 33F25J0897, 33F25L0347; ASK-04001-BW1/10801902117585/33F24D0105, 33F24G0277, 33F24H0240, 33F24J0546, 33F24K0158;