ARROW INTERNATIONAL, LLC recalls Description/REF: PSI KIT: 7 FR X 4IN ANTIMICROBIAL/ASK-0970

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: REF(Material)/UDI-DI/Lot(Batch): ASK-09701-UMH/10801902193275, 10801902139365, 10801902143874/33F24M0171, 33F25A0444, 33F25G0008, 33F25K0039, 33F25L0133, 33F26B0369, 33F23K0811; ASK-09803-OSU4/10801902212075, 10801902193275/33F24F0994, 33F24K0428, 33F25B0183, 33F25D0761; ASK-09903-AMC1/1080190219327, 10801902161830, 10801902136678/33F25A0437, 33F25E0024, 33F25G0690, 33F25L0142, 33F26C0117, 33F24B0612; ASK-09903-CMC1/10801902136678, 10801902193275/33F24D0050, 33F24D0965, 33F24F0130, 33F24J0321, 33F24J0627, 33F24L0585, 33F25A0110, 33F25C0176, 33F25C0588, 33F25E0212, 33F25E1020, 33F25F0324, 33F25G0753, 33F25L0208, 33F26A0396, 33F26A1255, 33F25E0716; ASK-09903-OSU4/10801902212006, 10801902193275/33F24G0022, 33F24L0298, 33F25D0762; ASK-09903-PCMH1/10801902193275, 20801902115205/33F25L0139, 33F26B0136, 33F24H0108; CDC-09803-1A/50801902116715, 10801902193275, 60801902116729/33F24D0892, 33F24F0766, 33F24L0274, 33F25B0147, 33F25C0497, 33F25C0498, 33F25D0553, 33F25E0647, 33F25F0209, 33F25H0574, 33F25L0121, 33F25M0410, 33F24D0504; ASK-09903-ECL3/10801902193275/33F25G0241, 33F25H0530, 33F25J0357, 33F26A0015; ASK-11242-PHP2/10801902193275, 10801902196436/33F24J0117, 33F24K0727, 33F25A0009, 33F25E0003, 33F25F0359, 33F25K0040, 33F25L0132, 33F26B0223, 33F26D0016, 33F24K0544; ASK-11142-NSU/10801902182545, 10801902193275/33F24E0326, 33F24K0354, 33F24L0244, 33F24L0300, 33F25B0189, 33F25C0228, 33F25D0467, 33F25E0591, 33F25G0272, 33F25G0405, 33F25H0629, 33F25J0363, 33F26A1572, 33F26B0816, 33F24L0840; AK-21242-X/10801902193275, 30801902122262, 80801902123127/33F24G0358, 33F24J0522, 33F24K0124, 33F24L0749, 33F25B0683, 33F25E0073, 33F25J0479, 33F25L0443, 33F26C0301, 33F24D0371; ASK-21142-DMC/10801902193275, 10801902218930, 10801902206685/33F25B0242, 33F25M0671, 33F26A0237, 33F26B0946, 33F24D0718; ASK-21142-GMC1/10801902193275, 10801902200492/33F25B0642, 33F25E0719, 33F25H0582, 33F25M0147, 33F26C0335, 33F24F0098; ASK-21142-HF5/10801902200492, 10801902193275, 10801902200492/33F24F0921, 33F24K0350, 33F24L0245, 33F25A0168, 33F25C0272, 33F25D0344, 33F25F0103, 33F25G0282, 33F25H0614, 33F25J0371, 33F26A1525, 33F26C0040, 33F24L0309; ASK-21142-LMDT/10801902193275, 10801902220728/33F25A0041, 33F25B0381, 33F25D0346, 33F25F0172, 33F25K0416, 33F25M0343, 33F26B0189, 33F26C0139, 33F25K0206; ASK-21142-UCL1/10801902193275/33F25E0541, 33F25G0391, 33F25J0102, 33F25J0373, 33F25M0235, 33F26A1375, 33F24H0098; ASK-21142-UPMC2/10801902159479, 10801902193275, 10801902225365/33F24F0879, 33F24J0161, 33F24L0310, 33F24L1023, 33F25C0276, 33F25E0780, 33F25G0348, 33F25J0209, 33F26A1371, 33F26A1547, 33R25G0348, 33F26C0490; ASK-21242-SL1/10801902193275/33F26A1347, 33F25E0314; ASK-21242-UMH/10801902129502, 10801902193275, 10801902156348/33F24E0637, 33F24F0895, 33F24L0317, 33F25B0197, 33F25C0280, 33F25D0478, 33F25F0178, 33F25H0564, 33F25L0106, 33F26A1517, 33F24F0618; ASK-21242-UN1/10801902193275, 10801902156348/33F24H0146, 33F25A0438, 33F25D0032, 33F25E0315, 33F25F0236, 33F25H0778, 33F25K0044, 33F26A0252, 33F26B0219, 33F26C0048, 33F25C0816; CDC-21142-XCN1A/10801902196498, 10801902193275/33F24E0226, 33F24E0242, 33F24E0254, 33F24F0250, 33F24G0203, 33F24H0356, 33F24H0391, 33F24J0220, 33F24L0078, 33F24M0018, 33F24M0054, 33F24M0206, 33F25A0130, 33F25A0385, 33F25B0068, 33F25B0340, 33F25C0076, 33F25C0510, 33F25D0697, 33F25D0733, 33F25E1092, 33F25E1101, 33F25F0435, 33F25G0027, 33F25H0334, 33F25H0814, 33F25J1006, 33F25K0310, 33F25L0090, 33F25L0277, 33F26A1615, 33F26A1622, 33F26A1623, 33F26A1645, 33F25B0528; CDC-21142-XN1A/10801902193275, 10801902196504, 50801902116821/33F25D0441, 33F25E0816, 33F25F0210, 33F25J0418, 33F26B0438, 33F26B0809, 33F26C0018, 33F24D0429; CDC-21242-XCN1A/10801902196511, 10801902193275, 10801902196511/33F24D0427, 33F24D0493, 33F24D0502, 33F24E0257, 33F24E0833, 33F24G0147, 33F24G0162, 33F24G0202, 33F24G0249, 33F24G0620, 33F24H0067, 33F24H0330, 33F24H0355, 33F24H0390, 33F24H0423, 33F24H0449, 33F24J0252, 33F24K0013, 33F24K0041, 33F24K0629, 33F24L0158, 33F24M0056, 33F24M0066, 33F24M0091, 33F25A0132, 33F25A0373, 33F25B0028, 33F25B0097, 33F25B0135, 33F25C0217, 33F25C0529, 33F25C0692, 33F25D0690,33F25D0692, 33F25D0698, 33F25D0707, 33F25D0721, 33F25D0734, 33F25D0754, 33F25E0415, 33F25E1102, 33F25E1123, 33F25E1152, 33F25F0030, 33F25F0039, 33F25F0484, 33F25F0525, 33F25H0335, 33F25H0872, 33F25J0747, 33F25J0774, 33F25K0292, 33F25K0353, 33F25L0092, 33F25L0236, 33F25L0298, 33F26A1617, 33F26A1626, 33F26A1632, 33F26A1635, 33F26B0621, 33F26B0622, 33F26B1039, 33F26D0229, 33F26D0230, 33X25J0002, 33F24H0395; CDC-21242-XN1A/10801902193275, 10801902196528, 20801902123484/33F25A0378, 33F25B0029, 33F25B0098, 33F25B0341, 33F25C0420, 33F25C0530, 33F25E1093, 33F25E1124, 33F25H0286, 33F25H0362, 33F25J0775, 33F25J1040, 33F26A1618, 33F26A1627, 33F26C0453, 33F26C0881, 33X25J0001, 33F24F0996; ASK-21142-CO1/10801902214291, 10801902193275/33F24F0767, 33F24K0423, 33F25B0548, 33F25D0266, 33F25F0170, 33F25H0592, 33F25K0136, 33F26A1450, 33F26C0489, 33F24J0113; ASK-21142-FH3/10801902206685, 10801902193275/33F24E0615, 33F24F0988, 33F24K0455, 33F24L0308, 33F24L0896, 33F25A0244, 33F25B0549, 33F25E0539, 33F25F0171, 33F25G0254, 33F25H0607, 33F26A1574; ASK-21142-OHSU3/10801902193275, 10801902188899, 10801902129953/33F25E1194, 33F25G0692, 33F25K0041, 33F25K0422, 33F26B0907, 33F24F0049; ASK-21142-SG2/10801902193275/33F25B0550, 33F25C0274, 33F25E0540, 33F25F0174, 33F25H0533, 33F25J0208, 33F26B0198, 33F26B0786, 33F25G0695; ASK-21142-UOI1/10801902193275, 10801902158878, 10801902159479/33F24J0014, 33F25A0013, 33F25B0425, 33F25E0012, 33F25G0553, 33F25H0773, 33F25K0042, 33F25L0259, 33F26A0236, 33F26C0115, 33F24D0800; ASK-21142-WHC2/10801902193275, 10801902134964/33F25B0643, 33F25D0473, 33F25E0857, 33F25F0114, 33F25J0210, 33F26C0338, 33F24H0148; ASK-21242-BID1/10801902193275, 10801902219135, 10801902220339/33F24L1014, 33F25B0644, 33F25E0594, 33F25F0091, 33F25F0346, 33F25H0454, 33F25J0211, 33F26C0376, 33F24F0067; ASK-21242-BSWH2/10801902220339, 10801902193275, 10801902160987/33F24F0965, 33F24K0451, 33F24L0311, 33F25A0298,33F25B0645, 33F25D0347, 33F25E0542, 33F25E0858, 33F25G0206, 33F25H0515, 33F25J0212, 33F25K0094, 33F25M0326, 33F26A1445, 33F26C0152, 33F24D0321; ASK-21242-DU1/10801902160987, 10801902193275, 10801902118407/33F24D0797, 33F24F0859, 33F24J0149, 33F24L1085, 33F25B0440, 33F25C0277, 33F25D0400, 33F25E0859, 33F25H0557, 33F25J0213, 33F25K0095, 33F24E0539; ASK-21242-PCMH1/10801902160987, 10801902193275, 10801902118407/33F24D0797, 33F24F0859, 33F24J0149, 33F24L1085, 33F25B0440, 33F25C0277, 33F25D0400, 33F25E0859, 33F25H0557, 33F25J0213, 33F25K0095, 33F24E0539; ASK-21242-UCH2/10801902219036, 10801902193275/33F24F0756, 33F24L1051, 33F25C0343, 33F25D0474, 33F25F0177, 33F25H0586, 33F25J0375, 33F26A1495, 33F26C0180, 33F26C0502, 33F25D0224; ASK-21242-UHC2/10801902193275, 10801902159639, 10801902114065/33F25D0349, 33F25F0115, 33F25G0349, 33F25H0634, 33F25J0377, 33F26C0173, 33F24D0662; ASK-29803-BSWH2/10801902220346, 10801902193275/33F24F1006, 33F24K0461, 33F24L0407, 33F25B0472, 33F25B0648, 33F25C0344, 33F25F0092, 33F25F0142, 33F25H0514, 33F25J0382, 33F25M0186, 33F26A1428, 33F26B0834, 33F26A0014; ASK-29803-HHC/10801902193275, 10801902211443/33F25A0213, 33F25B0442, 33F25F0181, 33F25G0247, 33F25J0152, 33F26B0174, 33F25E0548; ASK-29803-MCY1/10801902193275/33F24H0203, 33F24K0386, 33F24L0409, 33F25B0649, 33F25E0720, 33F25G0200, 33F25E0549; ASK-29803-UPM1/10801902193275, 10801902225136/33F24L0227, 33F24L0876, 33F25C0284, 33F25E0782, 33F25G0392, 33F25K0097, 33F25L0117, 33F26A1584, 33F26C0510; ASK-29804-VCU/10801902193275, 10801902112986/33F25E0551, 33F25F0360, 33F26B0225, 33F24L0889; ASK-29903-MCY1/10801902193275, 10801902221039, 10801902217087/33F24L0322, 33F25C0348, 33F25D0481, 33F25F0182, 33F25G0199, 33F25J0264, 33F26A1571, 33F26B0869, 33F24D0590; ASK-29903-MHI/10801902217087, 10801902193275/33F24F0808, 33F24L0831, 33F25B0474, 33F25E0555, 33F25H0458, 33F25J0265, 33F26C0341, 33F25F0008; ASK-29903-OHU4/10801902193275/33F25E0449, 33F25C0289; ASK-29903-UCH2/10801902193275/33F24K0489, 33F24L0410, 33F24L1024, 33F25C0350, 33F25F0183, 33F25H0587, 33F26A1458, 33F25H0438; ASK-29903-UCL1/10801902193275, 10801902144512/33F25J0385, 33F26B0713, 33F25B0200; ASK-29903-UHC4/10801902193275, 10801902159622/33F25F0184, 33F25H0470, 33F25J0154, 33F26B0123, 33F26C0025, 33F24H0118; ASK-29903-UPM1/10801902193275, 10801902159530, 10801902225174/33F24L0326, 33F25B0555, 33F25E0674, 33F25F0185, 33F25G0263, 33F25G0347, 33F25J0217, 33F25M0113, 33F26B0178, 33F26C0511; ASK-29907-LGH/10801902193275/33F25A0008, 33F25D0033, 33F25G0684, 33F25L0260, 33F25G0459; CDC-29803-1A/50801902117019, 10801902193275/33F24F0800, 33F24J0177, 33F24L0119, 33F24L1142, 33F25B0678, 33F25D0509, 33F25E0750, 33F25G0277, 33F25G0388, 33F25J0181, 33F26A1385, 33F26B0435, 33F25E0796; CDC-29903-1A/60801902117030, 10801902193275/33F24F0742, 33F24K0372, 33F24L0121, 33F24L1146, 33F25A0289, 33F25B0531, 33F25F0086, 33F25G0177, 33F25G0319, 33F25H0575, 33F25J0253 ,33F25M0106, 33F26A1491, 33F25J0671; CDC-29903-X1A/10801902193275, 20801902117049, 10801902193190/33F25J0679, 33F25J0726, 33F25K0187, 33F26A1553, 33F26C0352, 36F25B0022, 36F25G0002, 36F25G0019, 36F25G0025, 36F25H0007, 33F24E0229; CDC-29903-XCN1A/10801902193190, 10801902193275/33F24F0025, 33F24F0160, 33F24G0207, 33F24G0248, 33F24H0075, 33F24H0432, 33F24J0254, 33F24K0042, 33F24K0692, 33F24M0076, 33F24M0135, 33F25A0133, 33F25B0020, 33F25B0069, 33F25B0119, 33F25B0318, 33F25C0512, 33F25D0691, 33F25D0699, 33F25D0723, 33F25D0755, 33F25E1125, 33F25F0040, 33F25F0402, 33F25G0488, 33F25J0656, 33F25J0777, 33F25K0312, 33F25L0012, 33F25L0315, 33F25M0045, 33F26A1629, 33F26B0527, 33F26B0926, 33F26C0073, 33F26C0086, 33F26C0100, 33F26C0550, 33F25A0314; CDC-29903-XN1A/10801902193275, 10801902193206/33F25B0532, 33F25D0511, 33F25E0701, 33F25E0894, 33F25H0423, 33F25H0623, 33F25J0326, 33F26A1475, 33F26B0734, 33F26C0019, 33F25C0701; ASK-29903-AHH/10801902193275/33F25B0553, 33F25F0143, 33F25G0384, 33F25H0489, 33F25M0239, 33F24L0166; CDC-29803-XN1A/10801902193275, 10801902193121, 60801902117030/33F25D0510, 33F25E0700, 33F25E0893, 33F25G0337, 33F25J0252, 33F25M0400, 33F26B0152, 33F26B0733, 33F26B0820, 33F26C0009, 33F26C0582, 33F24D0888; ASK-04001-MM2/10801902193275, 10801902160086, 10801902114881/33F25B0428, 33F26B0220, 33F24D0538; ASK-21142-GMC/10801902189674/33F24K0062, 33F24K0670, 33F24M0044, 33F25A0105; ASK-21242-OSU3/10801902211986/33F24F0720, 33F24K0338, 33F24L0312;