Z-2391-2026 Class I Ongoing

Description/REF: RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-SPC; RA CATH KIT: 20 GA X 5 IN/ASK-04020-MW; ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM5; CATH SL 20 GA X 5 CM HYDROPHILIC/ASK-00520-JH; CATH S-L 20 GA X 5 CM HYDROPHILIC/ASK-00520-UHC; ARTERIAL LINE KIT: 20 GA x 5IN/ASK-00820-CL; RA CATH KIT: 20 GA X 8 CM X 12 CM/ASK-00820-WC; ARTERIAL CATHETERIZATION KIT/ASK-01218-HM; SAC KIT: 20 GA X 12CM/ASK-01220-HMH; ARTERIAL CATH KIT: 20GA X 12CM/ASK-01220-NWM; ARTERIAL CATH KIT: 20 GA X 12 CM/ASK-01220-UH; ARTERIAL CATH: 18 GA X 6 1/2IN/ASK-01618-AU; RA CATH KIT: 18 GA X 6 IN/ASK-01618-CL; ARTERIAL CATH KIT: 18 GA X 6 1/2 IN/ASK-01618-JH; ARTERIAL CATHETERIZATION KIT/ASK-01618-PH; ARTERIAL CATH KIT: 18 GA X 6 1/2IN/ASK-01618-RU; ARTERIAL CATH KIT: 18 GA X 6IN (16 CM)/ASK-04018-HF; ARTERIAL CATH KIT: 18 GA X 6 IN (16 CM)/ASK-04018-NS; ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018-ST; RA CATH KIT: 20 GA X 1 1/2 IN (3.81 CM)/ASK-04120-BGH; ART/VESS CATH KIT:20GAX4.45CM/20GAX12CM/ASK-04500-SM; ARTERIAL LINE KIT/ASK-04500-UCH; ARTERIAL LINE KIT/ASK-04510-EUH2; ARTERIAL LINE KIT: 20GA X 5IN (12CM)/ASK-04510-MS4; ARTERIAL LINE KIT/ASK-04510-UPM; ARTERIAL CATH KIT: 20GA X 5CM/SAC-00520-1A; ARTERIAL CATH KIT: 20GA X 5CM/SAC-00520-X1A; ARTERIAL CATH KIT: 22GA X 5CM/SAC-00522-1A ARTERIAL CATH KIT: 22 GA X 5CM/SAC-00522-X1A; ARTERIAL CATH KIT: 20GA X 8CM/SAC-00820-1A; ARTERIAL CATH KIT: 20GA X 8CM/SAC-00820-X1A; SAC KIT: 18 GA X 12CM/SAC-01218-1A; SAC KIT: 18 GA X 12CM/SAC-01218-X1A; SAC KIT: 20 GA X 12CM/SAC-01220-1A; SAC KIT: 20 GA X 12CM/SAC-01220-X1A; SAC KIT: 18 GA X 16CM/SAC-01618-1A; SAC KIT: 18 GA X 16CM/SAC-01618-X1A; ACCESS TRAY/UM-04018; RA CATH KIT: 20 GA X 4.45 CM/ASK-04020-ABM; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-BGH; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-LOL; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-MHS; RA CATH KIT: 20 GA X 1 3/4IN (4.45 CM)/ASK-04020-MIB3; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-PMC1; RA CATH SET: 20 GA X 1 3/4 IN/ASK-04020-URMC; RA CATH KIT: 20 GA X 1 1/2 IN (3.81 CM)/ASK-04220-FMH1; RA CATH KIT: 20 GA X 4.45 CM/NA-04020-1A; RA CATH KIT: 20 GA X 4.45 CM W BIO/NA-04020-B; RA CATH KIT: 20 GA X 4.45 CM W CHG/NA-04020-C; VESSEL CATH KIT: 20 GA X 5IN (12 CM)/ASK-04550-NYP; CVC KIT: 16 GA X 8 IN (20 CM)/ASK-04300-PHP1; CVC KIT: 16 GA X 8 IN (20 CM)/ASK-04301-TJ; ARTERIAL ACCESS KIT/ASK-04001-VAMC1; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-WBH

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): AK-04020-SPC/10801902121551, 10801902193275/33F23M0171, 33F24C0729, 33F24E0699, 33F24G0596, 33F24H0057, 33F24J0350, 33F24J0458, 33F24K0615, 33F24M0126, 33F25A0338, 33F25B0039, 33F25B0131, 33F25D0192, 33F25D0281, 33F25E1109, 33F25F0496, 33F25J0764, 33F26B0054; ASK-04020-MW/10801902142983, 10801902193275/33F23M0188, 33F24B0447, 33F24C0744, 33F24E0725, 33F24G0231, 33F24G0669, 33F24H0344, 33F24L0005, 33F24L0024, 33F25A0062, 33F25B0064, 33F25D0290, 33F25D0729, 33F25E0428, 33F25H0328, 33F26B0089, 33F26B0263; ASK-04510-MM5/10801902193275/33F24K0360, 33F25A0237, 33F25B0546; ASK-00520-JH/10801902138788, 10801902193275/33F24D0201, 33F24F0686, 33F24J0128, 33F24K0373, 33F25A0204, 33F25B0541, 33F25D0324, 33F25D0645, 33F25H0429, 33F25H0507, 33F25J0195, 33F26A1380, 33F26B0159, 33F26C0192; ASK-00520-UHC/10801902139839, 10801902193275/33F23L0771, 33F24A0775, 33F24B0219, 33F24C0125, 33F24D0093, 33F24E0383, 33F24G0386, 33F24J0284, 33F24K0149, 33F24L0712, 33F25A0495, 33F25C0125, 33F25C0826, 33F25E0099, 33F25H0047, 33F25J0851, 33F25L0392, 33F26B0540; ASK-00820-CL/10801902193275, 10801902193916/33F24G0275, 33F24J0285, 33F24K0152, 33F24L0590, 33F25A0497, 33F25C0797, 33F25E0102, 33F25H0050, 33F25J0853, 33F25L0385, 33F26B0536; ASK-00820-WC/10801902193275/33F24G0150, 33F24G0227, 33F24G0691, 33F24H0253, 33F24K0624, 33F25B0091, 33F25B0334, 33F25J0574, 33F26B0113; ASK-01218-HM/10801902193275/33F24G0276, 33F24K0551, 33F24L0215, 33F25A0296, 33F25B0543, 33F25E0450, 33F25F0364, 33F25G0163, 33F25G0208, 33F25H0499, 33F25J0100, 33F25J0139; ASK-01220-HMH/10801902193275/33F25B0245, 33F25B0544, 33F25C0698, 33F25D0388; ASK-01220-NWM/10801902193275/33F24H0181, 33F24J0154, 33F24K0497, 33F25F0157, 33F25H0658; ASK-01220-UH/10801902193275/33F24G0391, 33F24J0286, 33F24J0541, 33F24K0154, 33F24L0663, 33F25C0126, 33F25E0104, 33F25E0955, 33F25H0052, 33F25J0494, 33F25J0855, 33F25L0459, 33F25M0952; ASK-01618-AU/10801902205909, 10801902193275/33F24F0213, 33F24K0673, 33F25C0653, 33F25E1171, 33F25L0062, 33F26A0233; ASK-01618-CL/10801902195934, 10801902193275/33F24E0648, 33F24K0355, 33F25A0224,33F25B0493, 33F25D0327, 33F25E0588, 33F25F0158, 33F25J0140, 33F25M0112, 33F26C0366; ASK-01618-JH/10801902138801, 10801902193275/33F24D0584, 33F24K0490, 33F24L0844, 33F25B0494, 33F25D0530, 33F25H0834, 33F25K0264, 33F25K0357, 33S25D0530; ASK-01618-PH/10801902193275/33F24K0749, 33F24L0837, 33F25C0251, 33F25E0019, 33F25G0220; ASK-01618-RU/10801902202304, 10801902193275/33F24B0869, 33F24D1027, 33F25A0102, 33F25C0713, 33F25J0792, 33F25M0618; ASK-04018-HF/10801902193275/33F24H0156, 33F24L0397, 33F25D0391, 33F25G0401, 33F25K0069, 33F25M0142; ASK-04018-NS/10801902193275/33F25E1176, 33F25G0103; ASK-04018-ST/10801902117639, 10801902193275/33F24A0112, 33F24A0826, 33F24B0237, 33F24C0140, 33F24E0402, 33F24E0403, 33F24G0281, 33F24K0163, 33F25A0504, 33F25C0780, 33F25E0115, 33F25G0104, 33F25J0498, 33F25M0917, 33F26B1011; ASK-04120-BGH/10801902117936, 10801902193275/33F24D0518, 33F24G0262, 33F24J0474, 33F25A0150, 33F25C0740, 33F25E1207, 33F25H0096, 33F25K0331; ASK-04500-SM/30801902118012, 10801902193275/33F24A0117, 33F24A1163, 33F24D0059, 33F24D0968, 33F24E0782, 33F24G0263, 33F24J0302, 33F25C0500, 33F25E0162, 33F25H0738, 33F25L0209, 33F25M0617, 33F26B0020, 33F26B0746; ASK-04500-UCH/10801902139464, 10801902193275/33F24E0454, 33F24G0446, 33F24J0588, 33F24K0207, 33F24L0715, 33F25C0155, 33F25C0924, 33F25E0163, 33F25H0739, 33F25L0332, 33F26B0655; ASK-04510-EUH2/10801902193275, 10801902213386/33F24J0303, 33F24L0728, 33F25C0156, 33F25C0803, 33F25E0164, 33F25H0103, 33F25J0522, 33F25L0343, 33F25M0850, 33F26B0660; ASK-04510-MS4/10801902193275, 10801902139709/33F24K0212, 33F24L0764, 33F25C0860, 33F25E0169, 33F25E0994, 33F25J0526, 33F25L0423, 33F26B0654; ASK-04510-UPM/10801902118087, 10801902193275/33F24B0144, 33F24E0101, 33F24E0102, 33F24G0456, 33F24J0595, 33F24K0216, 33F24L0675, 33F25A0544, 33F25C0947, 33F25E0174, 33F25H0107, 33F25J0529, 33F25J0738, 33F25L0022, 33F26B0647, 33F26B0665, 33F26C0617; SAC-00520-1A/10801902140644, 10801902193275/33F24C0780, 33F24E0772, 33F24G0025, 33F24G0675, 33F24H0061, 33F24J0190, 33F24J0207, 33F24J0415, 33F24M0010, 33F25A0097, 33F25B0052, 33F25B0126, 33F25B0410, 33F25C0540, 33F25D0185, 33F25E0408, 33F25E0472, 33F25G0530, 33F25H0832, 33F25J0045, 33F25J1013, 33F25M0704, 33F26B0259; SAC-00520-X1A/10801902193275, 10801902140583/33F24J0208, 33F25A0098, 33F25B0023, 33F25B0127, 33F25B0287, 33F25D0086, 33F25E1180, 33F25F0288, 33F25F0425, 33F25H0347, 33F25H0866, 33F25L0177, 33F26B0058, 33F26B0279; SAC-00522-1A/10801902140606, 10801902193275/33F23L0976, 33F24B0461, 33F24C0783, 33F24E0775, 33F24G0243, 33F24J0242, 33F24J0416, 33F24M0122, 33F25A0389, 33F25B0076, 33F25E0382, 33F25H0348, 33F26B0257; SAC-00522-X1A/10801902193275/33F24L0536, 33F26B0059; SAC-00820-1A/10801902140637, 10801902193275/33F24B0463, 33F24C0785, 33F24E0777, 33F24F0081, 33F24G0136, 33F24H0059, 33F24H0352, 33F24H0388, 33F24L0057, 33F24M0011, 33F24M0123, 33F25A0134, 33F25B0109, 33F25B0282, 33F25B0646, 33F25C0543, 33F25C0568, 33F25D0094, 33F25D0186, 33F25D0302, 33F25E0364, 33F25F0045, 33F25J0581, 33F25J0980, 33F25K0298, 33F25K0338; SAC-00820-X1A/10801902193275, 10801902140620/33F25C0491, 33F25C0544, 33F25D0073, 33F25E0409, 33F25F0055, 33F25H0801, 33F25J0660, 33F25K0337, 33F25L0193, 33F25M0697, 33F26B0068, 33F26B0702; SAC-01218-1A/10801902199734, 10801902193275/33F24A1699, 33F24D0559, 33F24E0668, 33F24F1031, 33F25A0203, 33F25C0455, 33F25D0580, 33F25J0189, 33F26C0035; SAC-01218-X1A/10801902193275, 10801902199741/33F24J0138, 33F24L0960, 33F25A0294, 33F25B0537, 33F25C0479, 33F25E0768, 33F25H0618, 33F25J0451, 33F26A1374, 33F26B0775; SAC-01220-1A/10801902199758, 10801902193275/33F24C0971, 33F24D0361, 33F24F0986, 33F24L0509, 33F25A0221, 33F25B0481, 33F25C0374, 33F25D0635, 33F25E0711, 33F25G0297, 33F25J0133, 33F26A1362, 33F26B0458, 33F26C0680; SAC-01220-X1A/10801902193275, 10801902140989/33F24J0163, 33F24L0148, 33F25A0194, 33F25B0470, 33F25B0680, 33F25D0636, 33F25E0841, 33F25G0411, 33F25J0259, 33F26A1449, 33F26B0202, 33F26C0168; SAC-01618-1A/10801902199765, 10801902193275/33F24A0983, 33F24A1565, 33F24C0373, 33F24C1010, 33F24D0323, 33F24D0875, 33F24F0992, 33F24K0364, 33F24L0394, 33F24L1126, 33F25A0295, 33F25B0510, 33F25C0250, 33F25D0258, 33F25D0385, 33F25D0581, 33F25E0712, 33F25E0903, 33F25F0231, 33F25G0402, 33F25J0123, 33F25J0340, 33F26A1356, 33F26A1509, 33F26B0941, 33F26D0311; SAC-01618-X1A/10801902193275, 10801902145489/33F24J0144, 33F24L0395, 33F25A0222, 33F25B0511, 33F25D0259, 33F25D0321, 33F25D0458, 33F25E0770, 33F25F0232, 33F25G0264, 33F25G0383, 33F25J0134, 33F25J0452, 33F26A1435, 33F26B0842, 33F26B0939, 33F26B0940; UM-04018/10801902192063, 10801902193275/33F24A0359, 33F24A0360, 33F24A0361, 33F24A1061, 33F24A1062, 33F24B0162, 33F24B0163, 33F24B0164, 33F24C0053, 33F24D0042, 33F24D0043, 33F24H0463, 33F24H0464, 33F24J0466, 33F24K0306, 33F24K0311, 33F24K0543, 33F24L0723, 33F24L0761, 33F25A0608, 33F25C0209, 33F25E0284, 33F25E0297, 33F25E0742, 33F25E1061, 33F25E1069; ASK-04020-ABM/10801902193275, 10801902218947/33F24J0341, 33F24J0551, 33F24L0700, 33F25C0923, 33F25E0117, 33F25J0500, 33F25L0468, 33F26B0995; ASK-04020-BGH/10801902117660, 10801902193275/33F24A0814, 33F24C0142, 33F24D0109, 33F24E0406, 33F24G0404, 33F24J0554, 33F24L0634, 33F25A0507, 33F25C0809, 33F25E0120, 33F25H0064, 33F25J0867, 33F25L0386, 33F25M0890; ASK-04020-LOL/10801902193275, 10801902144765/33F24G0417, 33F24J0566, 33F24K0180, 33F24L0780, 33F25C0993, 33F25H0077, 33F25H0733, 33F25J0670, 33F25L0425, 33F26C0318, 33S24B0254, 33S24C0155; ASK-04020-MHS/20801902117711, 10801902193275/33F24A0380, 33F24A1033, 33F24B0255, 33F24C0157, 33F24D0121, 33F24E0420, 33F24H0476, 33F24J0568, 33F24K0181, 33F25C0990, 33F25E0137, 33F25G0111, 33F25H0078, 33F25J0505, 33F25L0377, 33F26B0526, 33S24A1033, 33S24B0255, 33S24C0157, 33S24D0121, 33X24K0003; ASK-04020-MIB3/10801902193275/33F24L0687, 33F25C0859, 33F25E0981, 33F25J0878, 33F26A0967; ASK-04020-PMC1/10801902193275/33F25C0489; ASK-04020-URMC/10801902117868, 10801902193275/33F24A0142, 33F24A0870, 33F24B0274, 33F24C0173, 33F24D0136, 33F24E0442, 33F24G0436, 33F24L0644, 33F25A0530, 33F25E0151, 33F25H0091, 33F25J0888; ASK-04220-FMH1/10801902193275/33F24K0203, 33F25A0535, 33F25E0158, 33F25J0890; NA-04020-1A/10801902119916, 10801902193275/33F24A1057, 33F24B0153, 33F24C0045, 33F24D0039, 33F24G0549, 33F24J0333, 33F24K0293, 33F24L0678, 33F25A0597, 33F25C0900, 33F25E0267, 33F25E1047, 33F25G0150, 33F25H0174, 33F25H0666, 33F25J0664, 33F25K0403, 33F25L0023, 33F25L0436, 33F25M0936, 33F26B0577; NA-04020-B/10801902193275, 10801902221312/33F24L0072, 33F25A0598, 33F25C0763, 33F25E0268, 33F25E1048, 33F25H0175, 33F25H0667, 33F25J0632, 33F26B0530; NA-04020-C/10801902193275, 10801902221329/33F24L0073, 33F25A0599, 33F25C0926, 33F25E0269, 33F25E1049, 33F25G0151, 33F25H0176, 33F25H0668, 33F26B0529; ASK-04550-NYP/10801902130836, 10801902193275/33F24F0685, 33F24H0144, 33F24K0424, 33F25A0166, 33F25B0170, 33F25B0495, 33F25D0337, 33F25G0355, 33F25H0431, 33F25H0639, 33F26A1367, 33F26A1542, 33F26C0585; ASK-04300-PHP1/10801902143805, 10801902193275/33F24F0619, 33F24H0147, 33F24K0072, 33F24M0047, 33F25C0649, 33F25K0314, 33F25L0029, 33F25M0066; ASK-04301-TJ/20801902114987, 10801902193275/33F24D0733, 33F24F0798, 33F25A0235, 33F25B0516; ASK-04001-VAMC1/10801902158854, 10801902193275/33F24E0400, 33F24G0400, 33F24K0161, 33F25A0502, 33F25E0114, 33F25J0863, 33F25L0387, 33F26B1016; ASK-04020-WBH/10801902117899/33F24C0174, 33F24D0138, 33F24E0445, 33F24G0438, 33F24J0582, 33F24L0793;