ARROW INTERNATIONAL, LLC
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
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: ACCESS TRAY/GU-04020; PSI KIT: 8.5 FR/AK-09803-CDC; PSI KIT: 9 FR/AK-09903-CDC; PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-09810-PCMH1; PSI KIT: 9 FR X 10 CM/ASK-09903-KH; PSI KIT: 9 FR X 10 CM/ASK-09903-PHP1; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-09903-UPA; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-YNH; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09907-SL; PSI KIT: 8.5 FR X 4-1/8IN (10 CM)/NA-09803-CDC; PSI KIT: 9 FR X 4-1/8IN (10 CM)/NA-09903-CDC; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-09903-ECL4; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-MGH3; MULTI-LUMEN/PSI KIT/AK-11142-SPCS; MAC KIT: 2-L 9 FR DISTAL X 11.5 CM/CDC-11242-1A; MULTI-LUMEN/PSI KIT/AK-11142-D; MULTILUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-11142-MGH4; MULTI-LUMEN/PSI KIT/NA-11242-CDC; MULTI-LUMEN/PSI KIT/AK-21142-SK; MAC KIT: 2L 9 FR DISTAL X 10 CM AGB/ASK-21142-LMDTG; MULTI LUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-21142-RH; MULTILUMEN/PSI KIT 9 FR X 11.5 CM/ASK-21242-IMC; MAC KIT: 2L 9 FR DISTAL X 11.5 CM AGB/ASK-21242-LMDTG; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UMD; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UU3; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-VCU; MAC KIT: 2L 9 FR DISTAL X 11.5 CM AGB/CDC-21242-1A; MAC KIT: 2L 9 FR DISTAL X 11.5 CM AGB/CDC-21242-X1A; MULTI-LUMEN/PSI KIT/AK-21242-CDC; 2L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-FH4; MULTI LUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-21142-GH1; 2L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-SUU; 2-L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-UPMC4; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UKL; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UMF; MULTILUMEN/PSI KIT: 9 FR X 4 1/2 IN/ASK-21242-UR1; PSI KIT: 8.5 FR/AK-29803-CDC; PSI KIT: 9 FR/AK-29903-CDC; PSI KIT: 9 FR/AK-29907-CDC; PSI KIT: 8.5 FR X 4IN (10 CM)/ASK-09804-UN1; PSI KIT: 9 FR/ASK-09903-UM; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/ASK-29803-LMDT; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/ASK-29803-LMDTG; PSI KIT: 9 FR X 4 1/8 (10 CM)/ASK-29903-BID1; PSI KIT: 9 FR X 10 CM ANTIMICROBI
REF(Material)/UDI-DI/Lot(Batch): GU-04020/30801902118807, 10801902193275, 30801902118807, 30801902118807/33F24C0753, 33F24E0736, 33F24G0154, 33F24G0648, 33F24H0377, 33F25A0059, 33F25A0072, 33F25A0395, 33F25F0260, 33F25G0736, 33F25H0298, 33F25J0603, 33F26B0084, 33F26B0314, 33F26C0578, 33F24D0036; AK-09803-CDC/20801902121756, 10801902193275, 10801902117417/33F24B0126, 33F24B0127, 33F24C0021, 33F24D0021, 33F24E0072, 33F24G0338, 33F24G0587, 33F24J0506, 33F24K0105, 33F24L0722, 33F25A0468, 33F25C0107, 33F25C0953, 33F25E0054, 33F25E0921, 33F25G0086, 33F25H0023, 33F25J0828, 33F25K0255, 33F25K0364, 33F25L0328, 33F24A0239; AK-09903-CDC/10801902117417, 10801902193275, 20801902121916/33F24A0356, 33F24B0128, 33F24B0129,33F24C0022, 33F24D0022, 33F24E0074, 33F24E0075, 33F24G0340, 33F24G0588, 33F24J0507, 33F24K0107, 33F24L0676, 33F24L0759, 33F25A0470, 33F25C0108, 33F25C0730, 33F25E0056, 33F25E0923, 33F25H0025, 33F25J0471, 33F25K0031, 33F25L0237, 33F25M0920, 33F26A1053, 33F24A0386; ASK-09810-PCMH1/10801902193275/33F25K0051, 33F24J0109; ASK-09903-KH/10801902119350, 10801902193275/33F24D0713, 33F24K0385, 33F24L1060, 33F25D0340, 33F25E0778, 33F25H0567, 33F25M0163, 33F26A1407, 33F25E1184; ASK-09903-PHP1/10801902193275, 10801902115222/33F24J0115, 33F25H0497, 33F26A0410, 33F24F0625; ASK-09903-UPA/10801902193275, 10801902118193/33F24K0387, 33F24L0855, 33F24A0787; ASK-09903-YNH/10801902118193, 10801902193275, 10801902118209/33F24E0527, 33F24H0478, 33F24L0682, 33F25H0135, 33F25J0915, 33F24A0110; ASK-09907-SL/10801902118209, 10801902193275/33F24D0053, 33F24D0967, 33F24G0265, 33F25E0215, 33F25E0454, 33F25G0680, 33F25J0551, 33F25K0328, 33F25L0206, 33F26C0312, 33F25B0188; NA-09803-CDC/10801902119930, 10801902193275, 10801902119947/33F24C0756, 33F24E0739, 33F25A0342, 33F25J0615, 33F26B0028, 33F24A1327; NA-09903-CDC/10801902119947, 10801902193275, 10801902119954/33F24E0740, 33F24H0381, 33F24J0199, 33F24J0361, 33F24L0020, 33F25B0278, 33F25C0551, 33F25E0340, 33F25E0400, 33F25E0468, 33F25F0419, 33F25H0708, 33F26A1655, 33F26B0023, 33F24A0113; ASK-09903-ECL4/10801902193275, 10801902224344/33F26A1582, 33F26B0399, 33F25E0534; ASK-09903-MGH3/10801902193275, 10801902189841, 10801902212006/33F25C0264, 33F25G0338, 33F25J0360, 33F25K0130, 33F26B0126, 33F26C0004, 33F24D0780; AK-11142-SPCS/10801902196412, 10801902193275, 60801902123093/33F24A0382, 33F24A1019, 33F24C0024, 33F24E0078, 33F24E0154, 33F24G0343, 33F24J0510, 33F24K0110, 33F24L0673, 33F25A0472, 33F25C0381, 33F25C0389, 33F25C0952, 33F25E0059, 33F25H0027, 33F25J0831, 33F25K0302, 33F25L0365, 33F26B0514, 33S24J0510, 33F24D0075; CDC-11242-1A/60801902116736, 10801902193275, 40801902111768/33F24D0431, 33F24E0213, 33F24F0140, 33F24F0220, 33F24G0103, 33F24H0392, 33F24H0425, 33F24H0450, 33F24L0011, 33F25B0018, 33F25B0096, 33F25D0705, 33F25E1120, 33F25F0024, 33F25F0414, 33F25G0043, 33F25G0486, 33F25J0016, 33F25J0992, 33F25K0308, 33F25M0481, 33F24C1001; AK-11142-D/20801902121916, 10801902193275, 10801902196412/33F24A1018, 33F24C0023,33F24E0077, 33F24G0342,33F24J0509, 33F24K0109, 33F24L0615, 33F25A0471, 33F25C0842, 33F25E0058, 33F25G0088, 33F25J0472, 33F25K0301, 33F25L0467, 33F26B0593, 33F26B0958, 33F24A0252; ASK-11142-MGH4/10801902193275, 10801902189865, 10801902182545/33F25D0466, 33F25F0113, 33F25L0130, 33F25M0398, 33F26A1539, 33F26B0680, 33F24D0736; NA-11242-CDC/10801902119954, 10801902193275, 10801902119978/33F24A0817, 33F24A1218, 33F24B0399, 33F24C0270, 33F24G0554, 33F24J0663, 33F24L0743, 33F25C0197, 33F25C0870, 33F25E0273, 33F25H0179, 33F25H0761, 33F25L0419, 33F26B0562, 33F24C0271; AK-21142-SK/10801902193275, 30801902122248, 30801902122255/33F24G0356, 33F24G0589, 33F24J0520, 33F24K0122, 33F24L0670, 33F25A0480, 33F25C0720, 33F25E0071, 33F25H0030, 33F25J0837, 33F25L0473, 33F25M0964, 33F26A1097, 33F26B0956, 33R24L0670, 33F24D0023; ASK-21142-LMDTG/10801902193275/33F25K0417, 33F25F0007; ASK-21142-RH/10801902193275/10801902129953/33F24J0108, 33F24L0165, 33F24M0172, 33F25B0422, 33F25E1172, 33F25H0776, 33F25K0424, 33F26C0337, 33F25A0245; ASK-21242-IMC/10801902193275, 10801902118407/33F24G0500, 33F24J0631, 33F24K0255, 33F24L0609, 33F25A0572, 33F25E0223, 33F25H0142, 33F25J0921, 33F26B0543, 33F25C0696; ASK-21242-LMDTG/10801902193275, 10801902220827/33F25G0202, 33F25H0414, 33F25K0382, 33F25M0130, 33F26C0378, 33F24H0123; ASK-21242-UMD/10801902193275/33F24K0476, 33F24L0315, 33F25B0196, 33F25C0279, 33F25D0476, 33F25H0492, 33F25J0378, 33F25M0150, 33F26A1365, 33F25B0551; ASK-21242-UU3/10801902193275/33F24G0503, 33F24L0652, 33F25C0181, 33F25E0226, 33F25H0144, 33F25J0556, 33F24K0077; ASK-21242-VCU/10801902193275, 10801902112962/33F24K0694, 33F25G0171, 33F25H0495, 33F25J0379, 33F26C0494, 33F25C0439; CDC-21242-1A/50801902116821, 10801902193275/33F24D0486, 33F24D0981, 33F24E0227, 33F24F0175, 33F24G0104, 33F24H0296, 33F24H0305, 33F24H0331, 33F24H0357, 33F24H0393, 33F24H0427, 33F24M0019, 33F24M0055, 33F25A0131, 33F25A0367, 33F25B0019, 33F25C0511, 33F25D0706, 33F25E0417, 33F25E1122, 33F25F0416, 33F25G0066, 33F25G0476, 33F25G0711, 33F25H0852, 33F25J0964, 33F25K0352, 33F25L0229, 33F26A1614, 33F26A1624, 33F26A1649, 33F24H0332; CDC-21242-X1A/10801902193275, 30801902116834, 10801902196511/33F25J0291, 33F25J0672, 33F25J0678, 33F25J0690, 33F25J0700, 33F25J0708, 33F25J0724, 33F25L0067, 33F26A1616, 33F26A1625, 33F26B0642, 36F25B0014, 36F25E0020, 36F25G0029, 36F25H0016, 36F25J0005, 33F24C0518; AK-21242-CDC/30801902122255, 10801902193275, 30801902122262/33F24E0082, 33F24E0083, 33F24J0521, 33F24K0123, 33F24L0618, 33F25A0481, 33F25C0946, 33F25E0072, 33F25H0031, 33F25K0037, 33F25K0414, 33F25L0372, 33F26B0520, 33F26C0626, 33F24E0352; ASK-21142-FH4/10801902193275/33F24L0683; ASK-21142-GH1/10801902193275/33F25C0180, 33F25E1023, 33F25H0141, 33F25H0752, 33F25J0920, 33F25L0455, 33F25B0276; ASK-21142-SUU/10801902193275/33F25J0096, 33F25C0275; ASK-21142-UPMC4/10801902193275/33F25A0247; ASK-21242-UKL/10801902114065, 10801902193275, 10801902136487/33F24F0710, 33F24K0467, 33F24L0314, 33F25B0195, 33F25C0278, 33F25D0475, 33F25G0412, 33F25J0149, 33F25M0202, 33F26A1551, 33F26C0010, 33F26C0759, 33F24F0849; ASK-21242-UMF/10801902193275, 10801902129502/33F25D0477, 33F25H0487, 33F25J0150, 33F25K0096, 33F24D0715; ASK-21242-UR1/10801902193275, 10801902119435, 10801902118902/33F25E0225, 33F25J0555, 33F25L0427, 33F25M0928, 33F26C0261, 33F24E0542; AK-29803-CDC/10801902193275, 20801902117506/33F24G0378, 33F24J0283, 33F24J0533, 33F24K0141, 33F24L0620, 33F25A0488, 33F25C0901, 33F25E0090, 33F25G0095, 33F25H0039, 33F25J0487, 33F25L0389, 33F25M0893, 33F26A1021, 33F26B0537, 33F26C0262, 33F24G0379; AK-29903-CDC/10801902193275, 10801902117516, 10801902117523/33F24J0345, 33F24J0534, 33F24K0142,33F24L0672, 33F25A0489, 33F25C0904, 33F25E0091, 33F25G0096, 33F25H0040, 33F25J0488, 33F25L0382, 33F25M0889, 33F26B0533, 33F24D0091; AK-29907-CDC/10801902117523, 10801902193275/33F24E0377, 33F24J0535, 33F24L0606, 33F25C0122, 33F25C0854, 33F25E0092, 33F25H0041, 33F25J0848, 33F26B0503, 33F25A0146; ASK-09804-UN1/10801902193275, 10801902145847/33F25H0485, 33F26A0248, 33F24B0018; ASK-09903-UM/10801902193275, 10801902118186/33F25B0432, 33F25F0361, 33F25L0136, 33F24D0545; ASK-29803-LMDT/10801902193275, 10801902220810/33F25H0367, 33F25J0153, 33F25K0258, 33F25K0418, 33F26A1354, 33F26C0357, 33F25G0464; ASK-29803-LMDTG/10801902193275, 10801902220858/33F25H0413, 33F25H0585, 33F25K0207, 33F25K0419, 33F25M0198, 33F25M0440, 33F26C0170, 33F24G0607; ASK-29903-BID1/10801902193275/33F25K0066, 33F26A0251, 33F24H0139; ASK-29903-LMDTG/10801902193275, 10801902220735/33F25L0025, 33F25M0338, 33F26C0021, 33F24H0124; ASK-29903-UMD/10801902193275/33F25C0583, 33F26A0409, 33F24K0402; ASK-29903-UR1/10801902193275/33F25J0796, 33F24J0107; CDC-29803-X1A/10801902193275, 30801902117022, 10801902193114/33F25F0334, 33F25H0878, 33F25J0292, 33F25K0016, 33F25K0315, 33F25M0088, 33F26A1415, 33F26B0473, 36F25E0019, 36F25G0020, 36F25H0013, 33F24E0214; ASK-29803-ECL/10801902193275, 10801902200478/33F26A1576, 33F24D0625; ASK-29803-UPM3/10801902193275/33F25B0236; ASK-29903-ECL/10801902193275/33F26A1580, 33F25D0235; ASK-29903-UPM3/10801902193275/33F25J0558; ASK-09907-TG1/10801902118216/33F24D1025
Data: U.S. FDA. 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. Open the enforcement explorer →