RecallHawk
Class I Recall

Description/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH; CVC KIT: 3-LUMEN 12 FR X 16 CM/AK-12123-F; CVC KIT: 3-L

ARROW INTERNATIONAL, LLC

Summary

The FDA issued a Class I for Description/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH; CVC KIT: 3-LUME by ARROW INTERNATIONAL, LLC. Reason: 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 q.

Details

Source

Device Recall

External ID

Z-2376-2026

Action Date

2026-06-24

Status

Ongoing

Category

device

Product Description

Description/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH; CVC KIT: 3-LUMEN 12 FR X 16 CM/AK-12123-F; CVC KIT: 3-LUMEN 12 FR X 20 CM/AK-15123-F; 3L CVC KIT: 7 FR X 16 CM/ASK-12703-PMAH; 3L PI CVC KIT: 7 FR X 16 CM/ASK-12703-PNM; 3L CVC KIT: 7 FR X 16 CM/ASK-12703-PUMH; MULTILUMEN PI CVC KIT: 3L 7 FR X 8 IN/ASK-15703-PRH; MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/CDC-15703-P1A; PI CVC KIT: 3-L 7 FR X 6IN (16 CM)/NA-12703-PCDC; PI CVC KIT: 3-L 7 FR X 8IN (20 CM)/NA-15703-PCDC; CVC KIT: 3-LUMEN 5.5 FR X 8 CM/AK-25553; 2-L CVC KIT: 4 FR X 5 CM/CDC-22402-X1A; 2-L CVC KIT: 5 FR X 5 CM/CDC-22502-X1A; 2-L CVC KIT: 4 FR X 8 CM/CDC-25402-X1A; 2-L CVC KIT: 5 FR X 8 CM/CDC-25502-X1A; 3-L CVC KIT: 5.5 FR X 8 CM/CDC-25553-X1A; 3-L CVC KIT: 5.5 FR X 13 CM/CDC-26553-X1A; CVC KIT 3L: 12 FR X 16 CM AGB/AK-22123-CDC; CVC KIT: 3-LUMEN 12 FR X 16 CM/AK-22123-F; CVC KIT: 2-LUMEN 4 FR X 5 CM/AK-22402; CVC KIT: 2-LUMEN 5 FR X 5 CM/AK-22502; CVC KIT: 16 GA X 8IN/AK-24301-SK; CVC KIT: 2-LUMEN 4 FR X 13 CM/AK-24402; CVC KIT: 3-LUMEN 7 FR X 30 CM/AK-24703-ASK; CVC KIT 3L: 12FR X 20 CM AGB/AK-25123-CDC; CVC KIT: 3-LUMEN 12 FR X 20 CM/AK-25123-F; CVC KIT: 2-LUMEN 4 FR X 8 CM/AK-25402; CVC KIT: 2-LUMEN 5 FR X 8 CM/AK-25502; CVC KIT: 3-LUMEN 5.5 FR X 13 CM/AK-26553; LBCVC KIT: 3L 12 FR X 16 CM AGB/CDC-22123-1A; LBCVC KIT: 3L 12 FR X 16 CM AGB/CDC-22123-X1A; CVC KIT: 16 GA X 20 CM/CDC-24301-1A; PI CVC KIT: 2L 7 FR X 16 CM AGB/AK-22702-P1A; PI CVC KIT: 2L 7 FR X 16 CM AGB/CDC-22702-XP1A; CVC KIT: 3L 7 FR X 20 CM/ASK-45703-CPR; MULTILUMEN PI CVC KIT: 3L 7 FR X 16 CM/ASK-42703-AKP1A; MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 6IN/ASK-42703-KH; PI CVC KIT: 3L 7FR X 16CM AGB+/ASK-42703-MGH1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 6IN/ASK-42703-PCCH2; PI CVC KIT: 3LUMEN 7 FR X 6IN (16 CM)/ASK-42703-PFS1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNO2; MULTI LUMEN PI CVC KIT: 3L 7 FR/ASK-42703-PSCH1; MULTILUMEN PI CVC KIT: 2L 8 FR X 16 CM/ASK-42802-AKP1A; CVC KIT: 2L 8 FR X 16CM/ASK-42802-LMDTG1; PI CVC KIT: 2L 8 FR X 6 IN (16 CM) AGB+/ASK-42802-PUCI1; PI CVC KIT: 2L 8 FR X 16 CM AGB+/ASK-42802-PUMH; PI CVC KIT: 2L 8 FR X 16 CM AGB+/ASK-42802-UMM; PI CVC KIT: 4-L 8.5 FR X 6 IN/ASK-42854-AKP1A; PI CVC KIT: 4L 8.5FR X 16CM AGB+/ASK-42854-MGH; MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-AKP1A; PI CVC KIT: 3L 7 FR X 20CM AGB+/ASK-45703-MGH; MULTI LUMEN PI CVC KIT: 3L 7 FR X 8 IN/ASK-45703-PCCH2; MULTI LUMEN PI CVC KIT: 3L 7 FR X 8 IN/ASK-45703-PECL1; PI CVC KIT: 3 LUMEN 7 FR X 8 IN (20 CM)/ASK-45703-PFS1; PI CVC KIT: 3L 7 FR X 8 IN (20 CM) AGB+/ASK-45703-PHM1; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PHU; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PMSG1; MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PNCB; MULTILUMEN CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PPCM; PI CVC KIT: 3-LUMEN 7 FR X 8 IN (20 CM)/ASK-45703-PRH; MULTILUMEN PI CVC KIT: 3L 7 FR X 8 IN/ASK-45703-PSJ2; PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PSVM; MULTI LUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PUHS; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PUKL; PI CVC KIT: 3L 7FR X 20CM AGB+/ASK-45703-PUMF1; PI CVC KIT: 3L 7 FR X 8 IN (20 CM)/ASK-45703-PUR1; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-RHR1; MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-WA; MULTI LUMEN PI CVC KIT: 2L 8 FR X 8 IN/ASK-45802-AKP1A; PI CVC KIT: 4L 8.5 FR X 20 CM/ASK-45854-AKP1A; PI CVC KIT: 4L 8.5FR X 20CM AGB+/ASK-45854-MGH; PI CVC KIT: 4L 8.5 FR X 8IN/ASK-45854-PCCH2; CVC KIT: 4L 8.5 FR X 20 CM AGB/ASK-45854-PNM; MULTI LUMEN CVC KIT: 4L 8.5 FR X 8 IN/ASK-45854-PPCM; PI CVC KIT: 4L 8.5 FR X 20 CM AGB+/ASK-45854-PUCH2; MULTILUMEN PI CVC KIT: 2L 7 FR X 20 CM/ASK-46702-PWBH1; MULTILUMEN CVC KIT: 2L 8 FR X 16 CM/CDC-42802-P1A; PI CVC KIT: 3-L 7 FR X 20 CM AGB/CDC-45703-PA1A; CVC KIT: 2L 8 FR X 6IN (16 CM)/ASK-42802-ECL4; PI CVC KIT: 3-L 7 FR X 16 CM AGB+/AK-42703-P1A; PI CVC KIT: 2-L 8 FR X 16 CM AGB+/AK-42802-P1A; PI CVC KIT: 4-L 8.5 FR X 16 CM AGB+/AK-42854-P1A; PI CVC KIT: 3-L 7 FR X 20 CM AGB+/AK-45703-P1A; PI CVC KIT: 2-L 8 FR X 20 CM AGB

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;

Quantity Affected: 308,263

Reason for Recall

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.

Distribution

US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.

Type: Voluntary: Firm initiated

Recall Initiated: 2026-04-21

Company

Context & Analysis

This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.

This was one of 254 device recalls issued in the same week, part of 413 device-related FDA actions this month.

ARROW INTERNATIONAL, LLC has 50 FDA actions in our database, including 47 recalls and 3 clearances.

Frequently Asked Questions

What is a Class I recall?

A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ARROW INTERNATIONAL, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does ARROW INTERNATIONAL, LLC have FDA actions?

ARROW INTERNATIONAL, LLC has 50 FDA actions in our database, including 47 recalls and 3 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-2376-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

Want to know the moment something like this happens?

Get alerts for device

Related Actions