ARROW INTERNATIONAL, LLC recalls Description/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-

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-42802-PLH/10801902193275, 10801902133110, 10801902212013/33F25L0140 33F26B0222, 33F24F0799; AK-12123-F/10801902168464, 10801902193275, 10801902186338/33F24B0185, 33F24C0102, 33F24D0077, 33F24F0323, 33F24G0346, 33F24K0112, 33F25C0929, 33F25E0062, 33F25H0028, 33F25J0833, 33F24G0129; AK-15123-F/10801902168525, 10801902193275, 10801902186499/33F24C0108, 33F24E0349, 33F24G0353, 33F24L0650, 33F25A0478, 33F25C0779, 33F25E0068, 33F25M0946, 33F24E0713; ASK-12703-PMAH/10801902193275/33F24J0116; ASK-12703-PNM/10801902193275, 10801902214338/33F24L0197, 33F24D0725; ASK-12703-PUMH/10801902193275, 10801902164602/33F25L0030, 33F24F0914; ASK-15703-PRH/10801902193275, 10801902133226/33F25C0271, 33F25F0168, 33F25J0101, 33F25J0368, 33F26A1500, 33F24C0858; CDC-15703-P1A/10801902116793, 10801902193275/33F24D0980, 33F24E0236, 33F24E0832, 33F24G0252, 33F24H0074, 33F24H0401, 33F24H0457, 33F24J0195, 33F24K0024, 33F24M0016, 33F24M0017, 33F24M0064, 33F25B0116, 33F25C0577, 33F25D0719, 33F25G0427, 33F25G0441, 33F25G0663, 33F25H0361, 33F25J1039, 33F25M0495, 33F25M0512, 33F25B0670; NA-12703-PCDC/10801902193275, 10801902119978, 10801902119985/33F24G0555, 33F24K0298, 33F25A0602, 33F25E1055, 33F25H0180, 33F25J0942, 33F25L0474, 33F26B0598, 33F24D0414; NA-15703-PCDC/10801902119985, 10801902193275, 10801902119985, 10801902210217/33F24F0191, 33F24G0556, 33F24J0336, 33F24K0572, 33F25A0157, 33F25C0200, 33F25C0833, 33F25E0275, 33F25H0181, 33F25H0762, 33F25J0943, 33F25L0456, 33F26B0587, 33F25A0603; AK-25553/10801902193275, 10801902167801/33F24H0250, 33F24M0062, 33F25A0382, 33F25B0310, 33F25C0069, 33F25C0506, 33F26C0405, 33F24G0377; CDC-22402-X1A/)10801902193275/33F25K0177, 33F26B0893, 33F25E1192; CDC-22502-X1A/10801902193275/33F25F0216, 33F25C0331; CDC-25402-X1A/10801902193275, 20801902116974/33F25A0287, 33F25D0505, 33F25E0824, 33F25H0569, 33F26A1470, 33F26B0216, 33F24L0486; CDC-25502-X1A/10801902193275/33F24L0980, 33F25D0506, 33F25E0698, 33F25G0315, 33F25J0429, 33F26A1472, 33F24L0832; CDC-25553-X1A/10801902193275, 10801902168129, 60801902123611/33F25E0890, 33F25E1191, 33F26A1384, 33F26B0708, 33F24F0084; CDC-26553-X1A/10801902193275, 10801902168136, 50801902117019/33F25E0749, 33F25E1190, 33F25J0432, 33F26B0807, 33F26C0210, 33F26D0063, 33F24D0807; AK-22123-CDC/10801902193275, 10801902167740/33F24K0127, 33F25A0483, 33F25E0076, 33F25E0938, 33F25H0032, 33F25J0480, 33F25K0398, 33F25M0960, 33F24E0358; AK-22123-F/10801902193275/33F24G0362, 33F24J0526, 33F24K0128, 33F24L0762, 33F25C0963, 33F25E0939, 33F25H0033, 33F24G0363; AK-22402/10801902193275, 10801902167764/33F24L0704, 33F25A0484, 33F25C0817, 33F25E0079, 33F25H0035, 33F25L0373, 33F25M0879, 33F24B0203; AK-22502/10801902193275, 10801902167764/33F24E0363, 33F24G0366, 33F24K0131, 33F24L0708, 33F25C0885, 33F25J0842, 33F24K0487; AK-24301-SK/10801902193275/33F24G0367, 33F24J0528, 33F24K0132, 33F24L0680, 33F25C0118, 33F25C0775, 33F25E0080, 33F25G0092, 33F25H0036, 33F25H0724, 33F25J0482, 33F25L0411, 33F25M0915, 33F24K0133; AK-24402/10801902193275/33F24L0059, 33F24L0727, 33F25C0119, 33F25C0976, 33F25E0081, 33F24K0134; AK-24703-ASK/10801902193275, 10801902118971, 60801902123178/33F24L0778, 33F25C0928, 33F25E0082, 33F25H0037, 33F25J0843, 33F26B0495, 33F24F0281; AK-25123-CDC/10801902193275/33F24K0136, 33F24L0730; AK-25123-F/10801902193275/33F25C0913, 33F25E0085, 33F25E0943, 33F25J0484, 33F26B0496, 33F24G0374; AK-25402/10801902193275, 10801902167795/33F24G0376, 33F24J0282, 33F24K0139, 33F24L0752, 33F25C0121, 33F25C0968, 33F25G0093, 33F25J0486, 33F25L0381, 33F26B0532, 33F24G0688; AK-25502/10801902193275, 10801902180381/33F24H0051, 33F24M0001, 33F25A0125, 33F25B0333, 33F25F0256, 33F25F0500, 33F25H0807, 33F25K0228, 33F25L0163, 33F26A0051, 33F26B0266, 33F24G0689; AK-26553/10801902193275, 20801902117506/33F24K0140, 33F24L0776, 33F25E0089, 33F25G0094, 33F25J0847, 33F25L0410, 33F25M0914, 33F24D0024; CDC-22123-1A/10801902168044, 10801902193275/33F24F0943, 33F24L0472, 33F25A0325, 33F25B0672, 33F25E0653, 33F25E0877, 33F25M0114, 33F25M0424, 33F26A1508, 33F25A0326; CDC-22123-X1A/10801902193275, 20801902116851, 20801902116851,10801902213591/33F25B0673, 33F25D0446, 33F25D0667, 33F25F0212, 33F25G0413, 33F25J0317, 33F25M0396, 33F26B0442, 33F24D0842; CDC-24301-1A/30801902116902, 10801902193275, 30801902116902, 30801902116919/33F24D0874, 33F24F0076, 33F24F0863, 33F24K0501, 33F24L0979, 33F25B0617, 33F25D0494, 33F25D0668, 33F25E0697, 33F25E0820, 33F25H0571, 33F25J0249, 33F25K0181, 33F25L0084, 33F25L0104, 33F26A1413, 33F26B0784, 33S25E0697, 33F24C0702; AK-22702-P1A/10801902193275, 30801902122378/33F25D0322, 33F25H0424, 33F25J0097, 33F25K0085, 33F24E0364; CDC-22702-XP1A/10801902193275, 30801902116896/33F25D0451, 33F25F0217, 33F25H0573, 33F25J0322, 33F26A1386, 33F26B0706, 33F25K0180; ASK-45703-CPR/10801902193275/33F24J0477, 33F24L1068; ASK-42703-AKP1A/10801902193275, 10801902202519/33F24J0324, 33F25A0577, 33F25C0841, 33F25E0233, 33F25E1027, 33F25G0140, 33F25H0148, 33F25H0754, 33F25J0924, 33F25M0869, 33F24F0754; ASK-42703-KH/10801902193275, 10801902205657/33F24G0269, 33F24L0087, 33F25E0235, 33F25G0141, 33F25L0213, 33F24D0891; ASK-42703-MGH1/10801902193275, 10801902223682, 10801902193275/33F25J0735, 33F26C0344, 33F25E0509; ASK-42703-PCCH2/10801902193275, 10801902141030/33F24L0231, 33F24L0416, 33F24L0945, 33F25B0443, 33F25B0561, 33F25D0352, 33F25E0726, 33F25G0316, 33F25J0155, 33F25M0013, 33F26B0792, 33F26C0228, 33F25D0540; ASK-42703-PFS1/10801902193275/33F25E0598, 33F25B0275; ASK-42703-PNO2/10801902193275/33F26A1661, 33F24L0335; ASK-42703-PSCH1/10801902137330, 10801902193275/33F24F1038, 33F24H0204, 33F25B0566, 33F25H0491, 33F25J0274, 33F25M0092, 33F26B0124, 33F24H0100; ASK-42802-AKP1A/10801902193275, 10801902217155/33F24G0511, 33F24K0264, 33F24L0745, 33F25C0931, 33F25H0150, 33F25J0561, 33F25L0481, 33F25M0971, 33F24F0676; ASK-42802-LMDTG1/10801902193275, 10801902205701/33F26A1254, 33F26B0814, 33F24H0215; ASK-42802-PUCI1/10801902193275/33F24L0195; ASK-42802-PUMH/10801902193275, 10801902164251/33F25H0493, 33F25K0059, 33F25L0141, 33F25M0674, 33F24D0712; ASK-42802-UMM/10801902159653, 10801902193275/33F24F1027, 33F24G0513; ASK-42854-AKP1A/10801902193275, 10801902202540/33F24J0635, 33F24K0265, 33F24L0610, 33F25A0580, 33F25E0239, 33F25H0152, 33F25J0562, 33F24E0632; ASK-42854-MGH/10801902223668, 10801902193275/33F26C0876, 33F25E1198; ASK-45703-AKP1A/10801902193275, 10801902158120/33F24G0515, 33F24J0636, 33F24K0266, 33F24L0577, 33F25A0581, 33F25C0843, 33F25E0241, 33F25G0142, 33F25H0154, 33F25J0564, 33F25L0238, 33F25M0902, 33F24F0106; ASK-45703-MGH/10801902223675/33F26C0875, 33F25B0580; ASK-45703-PCCH2/10801902193275, 10801902141047, 10801902193275/33F24L0356, 33F24L1092, 33F25B0582, 33F25D0550, 33F25E0615, 33F25G0352, 33F25J0163, 33F25K0154, 33F26B0772, 33F24L0088; ASK-45703-PECL1/10801902193275, 10801902130386/33F25E0618, 33F25F0204, 33F25G0289, 33F25J0167, 33F25M0192, 33F26B0191, 33F26B0765, 33F25C0313; ASK-45703-PFS1/10801902193275/33F25E0510, 33F25B0274; ASK-45703-PHM1/10801902193275, 10801902116229/33F25E0620, 33F25G0290, 33F25H0572, 33F25J0405, 33F26B0715, 33F26B0854, 33F25K0313; ASK-45703-PHU/10801902193275/33F25L0135, 33F26A0243, 33F25G0685; ASK-45703-PMSG1/10801902193275, 30801902116315/33F25E1199, 33F25F0357, 33F26A0411, 33F24D0674; ASK-45703-PNCB/30801902116315, 10801902193275/33F24F0818, 33F24L0256, 33F24L1075, 33F25B0592, 33F25D0486, 33F25E0731, 33F25H0433, 33F25M0159, 33F25M0426, 33F26B0760, 33F25B0456; ASK-45703-PPCM/10801902193275, 10801902116335/33F25F0358, 33F25G0688, 33F25K0048, 33F25L0028, 33F26B0903, 33F24K0067; ASK-45703-PRH/10801902193275, 10801902116359, 10801902116373/33F25A0275, 33F25C0318, 33F25E0807, 33F25G0358, 33F25J0301, 33F26A1420, 33F26B0799, 33F24E0560; ASK-45703-PSJ2/10801902193275, 10801902119732/33F25C0319, 33F25E0733, 33F25G0357, 33F25H0641, 33F25J0302, 33F26A1507, 33F26B0878, 33F24L0259; ASK-45703-PSVM/10801902119749, 10801902193275, 10801902119749/33F24F0755, 33F24L0446, 33F25B0459, 33F25C0320, 33F25D0551, 33F25F0120, 33F25G0356, 33F25J0303, 33F26A1523, 33F26B0762, 33F25D0237; ASK-45703-PUHS/10801902193275, 10801902114058/33F24L0942, 33F25B0596, 33F25E0687, 33F25G0303, 33F25H0642, 33F26A1424, 33F24F0717; ASK-45703-PUKL/10801902193275, 10801902114058, 10801902193275/33F24H0185, 33F24K0433, 33F24L0262, 33F25B0597, 33F25D0372, 33F25E0628, 33F25H0566, 33F25J0173, 33F26B0233, 33S25E0628, 33F25B0461; ASK-45703-PUMF1/10801902193275/33F25K0060, 33F25L0134, 33F26A0235, 33F24K0567; ASK-45703-PUR1/10801902116465, 10801902193275/33F24F0790, 33F24H0206, 33F24L0266, 33F24L0922, 33F25B0601, 33F25D0375, 33F25E0630, 33F25E0870, 33F25J0408, 33F25M0128,33F26A1432, 33F26B0836, 33F24G0616; ASK-45703-RHR1/10801902116465, 10801902193275/33F24F0790, 33F24H0206, 33F24L0266,33F24L0922, 33F25B0601,33F25D0375, 33F25E0630, 33F25E0870, 33F25J0408, 33F25M0128, 33F26A1432, 33F26B0836, 33F24G0616; ASK-45703-WA/10801902193275, 10801902116564, 30801902119774/33F25A0443, 33F25E0011, 33F25K0309, 33F26B0909, 33F24C0746; ASK-45802-AKP1A/10801902193275, 30801902119774/33F24L0023, 33F26A1657, 33F26B0277, 33F25D0034; ASK-45854-AKP1A/10801902193275, 30801902119781/33F24G0671, 33F24L0039, 33F25A0366, 33F25B0094, 33F25D0715, 33F25G0495, 33F25J0033, 33F25K0349, 33F25L0226, 33F26A1654, 33F26B0025, 33F26B0698, 33F24J0130; ASK-45854-MGH/10801902223699, 10801902193275/33F26C0688, 33F25C0363; ASK-45854-PCCH2/10801902193275/33F25J0234, 33F25E1175; ASK-45854-PNM/10801902193275/33F24K0570, 33F25B0431, 33F25E0006, 33F25F0377, 33F25H0780, 33F25L0261; ASK-45854-PPCM/10801902143867/33F24F0736; ASK-45854-PUCH2/10801902193275/33F24M0177; ASK-46702-PWBH1/10801902193275/33F24K0321, 33F24K0269; CDC-42802-P1A/10801902170870, 10801902193275, 10801902170870/33F24F0244, 33F24H0070, 33F24H0426, 33F24J0223, 33F24J0468,33F24L0009,33F24M0079, 33F24M0139, 33F25B0319, 33F25C0533, 33F25E1094, 33F25E1156,33F25F0384, 33F25H0338, 33F25J0766, 33F25J0990, 33F25L0086, 33F25M0016, 33F26A1619, 33F26B1051, 33F25H0880; CDC-45703-PA1A/10801902193275, 30801902117190, 10801902117202/33F24M0081, 33F25F0241, 33F26A1656, 33F26B0334, 33F24C1072; ASK-42802-ECL4/10801902224283, 10801902205664/33F26B0489, 33F24D0651; AK-42703-P1A/10801902193275, 10801902171372/33F25D0323, 33F25D0585, 33F25F0122, 33F25F0153, 33F25G0376, 33F25J0135, 33F26B0459, 33F24L1104; AK-42802-P1A/10801902193275/33F25B0539, 33F25D0386, 33F25F0137, 33F25J0136, 33F25B0512; AK-42854-P1A/10801902193275, 10801902168167, 10801902119152/33F25E0664, 33F25H0442, 33F25J0341, 33F26B0752, 33F23H0557; AK-45703-P1A/10801902193275, 10801902171389/33F25C0341, 33F25D0387, 33F25D0643, 33F25F0154, 33F25G0257, 33F25G0375, 33F25J0137, 33F25J0342, 33F26A1416, 33F26B0150, 33F26B0766, 33F25C0191; AK-45802-P1A/10801902193275, 10801902168181/33F25E0665, 33F25J0191, 33F26B0754, 33F25A0223; AK-45854-P1A/10801902193275, 10801902168198/33F25D0459, 33F25F0138, 33F26B0145, 33F25B0540; AK-47702-P1A/10801902193275/33F25E0502, 33F25G0162, 33F25H0407, 33F25J0343, 33F24G0383; ASK-42703-PECL3/10801902193275/33F26A1397, 33F25B0562; ASK-42703-PUPM3/10801902225150, 10801902156966/33F26C0238, 33F24F0977; ASK-42802-PUPM3/10801902225143, 10801902193275/33F26C0239, 33F25B0498; ASK-45703-PECL3/10801902193275, 10801902224313/33F26A1577, 33F26B0773, 33F25C0234; ASK-45703-PUPM3/10801902225181, 10801902116465/33F26C0219, 33F24D0840; ASK-45854-PECL3/10801902193275/33F24L0191; ASK-45854-PUPM3/10801902225167, 10801902193275/33F26C0240, 33F24H0111; ASK-45854-SMW/10801902224436, 10801902214888/33F26B0830, 33F24F0872; CDC-42802-XP1A/10801902193275, 10801902168365, 10801902162103/33F25J0295, 33F25J0728, 33F25K0304, 33F25K0390, 33F25L0228, 33F25M0037, 33F25M0485, 33F25M0717, 33F26A1630, 36F25C0008, 36F25D0001, 36F25D0034, 36F25E0001, 36F25G0022, 36F25H0015, 33F24D0258; CDC-42854-XP1A/10801902193275, 20801902117148, 10801902162134/33F25J0681, 33F26A0390, 33F26C0209, 33F26D0062, 36F25D0003, 36F25H0014, 33F24D0827; CDC-45703-XP1A/10801902193275, 20801902117216/33F25G0286, 33F25H0876,33F25J0089,33F25J0682, 33F25J0702, 33F25J0705, 33F25J0711,33F25J0718, 33F25J0729, 33F25J0733, 33F25K0305, 33F25L0063,33F25L0093, 33F25L0094, 33F25L0231, 33F25L0252, 33F25L0253, 33F25L0254, 33F25L0286, 33F25L0302, 33F25L0322, 33F25M0487, 33F26A0062, 33F26B0637, 33F26B0638, 33F26D0185, 36F25A0008, 36F25A0014, 36F25D0010, 36F25D0011, 36F25D0014, 36F25D0021, 36F25D0022, 36F25D0023, 36F25D0028, 36F25D0041, 33F25C0372; CDC-45854-XP1A/10801902193275, 10801902169720, 10801902162158/33F25J0695, 33F25J0730, 33F25K0394, 33F26A1620, 33F26B0572, 33F26B0735, 36F25G0003, 36F25G0021, 36F25G0024, 36F25H0011, 36F25H0017, 33F24D0424 ASK-42703-PGM3/10801902213751/33F24F0951, 33F24K0743; ASK-42802-UH1/10801902156386/33F24H0122; ASK-45703-PGM3/10801902213768/33F24D0844, 33F24F0840;