Description/REF: RA CATH KIT: 20 GA X 1 3/4 IN/TJ-04020-1; RA CATH KIT: 20 GA X 1 1/2IN/NA-0422...
FDA Device Recall #Z-2368-2026 - Class I, April 21, 2026
Recall Summary
| Recall Number | Z-2368-2026 |
| Classification | Class I - Serious risk |
| Date Initiated | April 21, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | ARROW INTERNATIONAL, LLC |
| Location | Morrisville, NC |
| Product Type | Devices |
| Quantity | 785,999 |
Product Description
Description/REF: RA CATH KIT: 20 GA X 1 3/4 IN/TJ-04020-1; RA CATH KIT: 20 GA X 1 1/2IN/NA-04220-S1A; ARTERIAL LINE KIT/AK-04510-S; ARTERIAL CATH KIT: 18 GA X 6IN (16 CM)/ASK-04018-HUMC; ARTERIAL LINE KIT: 18 GA X 6 IN (16 CM)/ASK-04018-OH1; RA CATH KIT: 20 GA X 1 3/4IN (4.45 CM)/ASK-04020-BID; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-MAR; ARTERIAL LINE KIT: 20 GA X 5 IN/ASK-04020-PM4; RA CATH KIT: 20 GA X 1 1/2IN (3.81 CM)/ASK-04120-HF3; RA CATH SET: 20 GA X 2 1/2 IN (6.35 CM)/ASK-04120-UR; ARTERIAL CATH KIT: 20 GA X 3 1/16 IN/ASK-04125-MGH; ARTERIAL CATH KIT: 20 GA X 5 IN/ASK-04500-HFH4; ARTERIAL LINE KIT: 20GA X 5IN/ASK-04510-BID2; ARTERIAL LINE KIT: 20GA X 5IN (12 CM)/ASK-04510-EHP1; ARTERIAL LINE KIT/ASK-04510-FEM1; ARTERIAL LINE KIT: 20 GA X 5 IN (12 CM)/ASK-04510-HFH; ARTERIAL CATH KIT: 20 GA X 5 IN/ASK-04510-HFH4; ARTERIAL LINE KIT/ASK-04510-SE; ARTERIAL LINE KIT: 20 GA X 5 IN (12CM)/ASK-04510-TGH2; RA CATH KIT: 20 GA X 12 CM/NA-04550-1A; RA CATH KIT: 20 GA X 12 CM/NA-04550-X1A; RA CATH KIT: 18 GA X 1-3/4IN/AK-04018; RA CATH KIT: 20 GA X 1-3/4IN/AK-04020; RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-C; RA CATH KIT: 20 GA X 1-1/2IN/AK-04120; RA CATH KIT: 22 GA X 1-3/8IN/AK-04122; RA CATH KIT: 20 GA X 1-1/2IN/AK-04220; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-AH; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-ATH; RA CATH KIT: 20 GA X 1 3/4IN (4.45CM)/ASK-04020-AU2; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-BHS; ARTERIAL CATHETERIZATION KIT/ASK-04020-BIDB2; RA CATH KIT: 20 GA X 4.45 CM/ASK-04020-CCD1; ARTERIAL CATHETERIZATION KIT/ASK-04020-CR; ART LINE KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-EUH2; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-FAM1; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-FMC; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-KSF2; RA CATH KIT: 20 GA X 1 3/4 IN (4.5 CM)/ASK-04020-LHC2; RA CATH KIT: 20 GA X 1 3/4 IN (4.5 CM)/ASK-04020-LHC3; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-LM; RA CATH KIT: 20 GA X 1 3/4IN/ASK-04020-MCH1; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MIH1; RA CATH KIT: 20 GA X 4.45 CM/ASK-04020-NWMX; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-PHP; RA CATH KIT: 20 GA X 1-3/4 IN (4.45CM)/ASK-04020-RIHM; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-RMC1; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-RU; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-SE; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-SHM; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-SRMC1; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-UCL1; RA CATH KIT: 20 GA X 4.45 CM/ASK-04020-UMI; RA CATH KIT: 20 GA X 1-3/4 IN (4.45CM)/ASK-04020-UN; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-UNC; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-UNC1; RA CATH SET: 20 GA X 1-1/2IN (3.81CM)/ASK-04220-PSU; RA CATH KIT: 20 GA X 1-1/2 IN (3.81 CM)/ASK-04220-UCL1; RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-S1A; CVC KIT: 20 GA X 5 IN (12CM)/ASK-04550-JMC1; ARTERIAL ACCESS TRAY/ASK-04001-BW2; ARTERIAL ACCESS TRAY WITH .025 IN SWG/ASK-04001-WUH1; ARTERIAL LINE KIT/ASK-04510-HUM
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 Pattern
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.
Lot / Code Information
REF(Material)/UDI-DI/Lot(Batch): TJ-04020-1/10801902193275, 30801902202155/33F24J0338, 33F25A0158, 33F25C0753, 33F25E0281, 33F24B0409; NA-04220-S1A/10801902193275/33F25E1052, 33F24G0553; AK-04510-S/10801902192230, 10801902193275, 10801902196719/33F24A0337, 33F24A0338, 33F24A0339, 33F24A0341, 33F24A0342, 33F24A0343, 33F24A1012, 33F24B0107, 33F24B0108, 33F24B0109, 33F24B0110, 33F24B0111, 33F24C0010, 33F24C0011, 33F24D0015, 33F24D0016, 33F24E0046, 33F24E0047, 33F24G0327, 33F24G0570, 33F24G0571, 33F24G0572, 33F24G0573, 33F24G0574, 33F24G0575, 33F24J0493, 33F24J0674, 33F24J0675, 33F24J0676, 33F24J0677, 33F24K0091, 33F24K0309, 33F24K0313, 33F24L0623, 33F24L0627, 33F24L0629, 33F24L0631, 33F24L0754, 33F24L0783, 33F25A0457, 33F25A0613, 33F25A0614, 33F25A0615, 33F25A0616, 33F25C0738, 33F25C0751, 33F25C0794, 33F25C0846, 33F25C0907, 33F25C0955, 33F25C0956, 33F25E0040, 33F25E0288, 33F25E0289, 33F25E0290, 33F25E0910, 33F25E1065, 33F25E1066, 33F25G0079, 33F25G0158, 33F25H0012, 33F25H0193, 33F25H0194, 33F25H0195, 33F25H0196, 33F25J0464, 33F25J0642, 33F25J0789, 33F25J0801, 33F25J0802, 33F25J0803, 33F25J0804, 33F25L0486, 33F25L0488, 33F26B0668, 33F26B0669, 33F26B0671, 33F26B0672, 33F23L0360; ASK-04018-HUMC/10801902193275/33F25B0360, 33F25K0050, 33F25M0680, 33F25E1176; ASK-04018-OH1/10801902117622, 10801902193275, 10801902117622, 10801902117639/33F24F0741, 33F24L0218, 33F24L0865, 33F25B0173, 33F25C0253, 33F25E0667, 33F25F0162, 33F25J0143, 33F26A1440, 33F26B0794, 33F24A0112; ASK-04020-BID/10801902211429, 10801902193275, 10801902211429/33F24D0870, 33F24E0650, 33F24F0646, 33F24L0220, 33F24L0399, 33F25B0175, 33F25D0335, 33F25E0668, 33F25G0248, 33F25L0123, 33F26A0254, 33F26A1441, 33S23J0777, 33F24G0405; ASK-04020-MAR/10801902193275, 10801902159776/33F24J0567, 33F24L0586, 33F25A0519, 33F25E0136, 33F25E0979, 33F25G0675, 33F25J0504, 33F25L0210, 33F26B0742, 33F25K0032; ASK-04020-PM4/10801902138498, 10801902193275, 10801902138498, 30801902158896/33F24E0428, 33F24E0429, 33F24G0424, 33F24K0188, 33F24L0789, 33F25C0142, 33F25C0821, 33F25E0142, 33F25H0085, 33F25J0883, 33F25L0470, 33F26B0659, 33F24F0095; ASK-04120-HF3/10801902200447, 10801902193275, 10801902200447, 10801902117943/33F24D0857, 33F24F0638, 33F24H0168, 33F24K0389, 33F24L0289, 33F25D0336, 33F25F0126, 33F25F0163, 33F25H0616, 33F25J0202, 33F25M0158, 33F25M0362, 33F26A1429, 33F26B0127, 33S24A1516, 33S24C0854, 33F24A0136; ASK-04120-UR/10801902117943, 10801902193275, 10801902117943/33F24A0769, 33F24B0278, 33F24C0175, 33F24D0140, 33F24E0447, 33F24G0287, 33F24K0201, 33F25B0692, 33F25C0962, 33F25E0156, 33F25H0097, 33F25J0889, 33F25L0383, 33F26C0309, 33F24G0441; ASK-04125-MGH/10801902193275, 10801902139976/33F24J0584, 33F25C0985, 33F25D0307, 33F25E0157, 33F25E0990, 33F25H0098, 33F25J0519, 33F25L0421, 33F26A1057, 33F26B0983, 33F24K0203; ASK-04500-HFH4/10801902200461, 10801902193275, 10801902118001/33F24E0651, 33F24F0722, 33F24L0292, 33F25C0437, 33F25D0228, 33F25E0775, 33F25F0109, 33F25F0164, 33F25H0615, 33F25M0345, 33F26A1363, 33F26B0405, 33S24C0436, 33S24L0292, 33F24A0141; ASK-04510-BID2/10801902193275, 10801902211412, 10801902115024/33F24J0171, 33F25A0165, 33F25C0438, 33F25D0229, 33F25E0852, 33F25G0249, 33F25J0204, 33F25M0233, 33F26A1443, 33F26B0410, 33F24F0820; ASK-04510-EHP1/10801902193275, 10801902115024/33F24L0293, 33F25C0192, 33F25D0230, 33F25E0589, 33F25E0853, 33F25H0646, 33F25L0125, 33F26A0255, 33F26A1520, 33F26B0838, 33F24J0303; ASK-04510-FEM1/10801902214796, 10801902193275/33F24A0831, 33F24B0286, 33F24C0185, 33F24E0456, 33F24E0457, 33F24G0448, 33F24J0304, 33F24L0771, 33F25A0539, 33F25E0165, 33F25G0118, 33F25J0523, 33F26A1051, 33F26B0658, 33F24J0591; ASK-04510-HFH/10801902115031, 10801902193275, 10801902200454/33F24G0053, 33F24L0022, 33F24M0108, 33F24M0190, 33F25A0126, 33F25A0356, 33F25A0384, 33F25B0043, 33F25D0200, 33F25H0329, 33F25H0848, 33F25J0613, 33F26A1358, 33F26B0677, 33F24D0865; ASK-04510-HFH4/10801902200454, 10801902193275/33F24F0865, 33F24J0167, 33F24L0965, 33F25A0236, 33F25C0260, 33F25E0776, 33F25G0332, 33F25J0205, 33F25M0276, 33F26A0305, 33F26B0194, 33F24J0306; ASK-04510-SE/10801902193275, 20801902214038, 10801902217018/33F24K0213, 33F24L0592, 33F25B0251, 33F25C0159, 33F25E0171, 33F25J0527, 33F25L0333, 33F26B0664, 33F24A0873; ASK-04510-TGH2/10801902217018, 10801902193275, 10801902118070/33F24B0292, 33F24C0188, 33F24E0463, 33F24G0289, 33F24K0214, 33F24L0633, 33F25A0542, 33F25C0879, 33F25E0172, 33F25G0120, 33F25J0528, 33F25L0354, 33F25M0862, 33F24C0189; NA-04550-1A/30801902117367, 10801902193275, 33F24A1562, 33F24C0709, 33F24D0331, 33F24E0628, 33F24F0946, 33F24K0382, 33F24L0144, 33F24L1015, 33F25C0223, 33F25D0320, 33F25E0512, 33F25E0663, 33F25E0839, 33F25J0187, 33F25K0199, 33F24K0374; NA-04550-X1A/10801902193275, 30801902117374, 10801902119930/33F24K0704, 33F24L0145, 33F24L1138, 33F25C0465, 33F25C0472, 33F25D0633, 33F25G0387, 33F25J0188, 33F25K0200, 33F26C0354, 33F26C0763, 33F24A1326; AK-04018/10801902190915, 10801902193275, 10801902190939/33F24E0696, 33F24L0051, 33F25A0353, 33F25B0078, 33F25D0714, 33F25G0732, 33F25J0593, 33F26B0039, 33F24A1251; AK-04020/10801902190939, 10801902193275, 60801902121549, 10801902121551/33F24C0727, 33F24C1254, 33F24D0439, 33F24E0697, 33F24F0010, 33F24G0049, 33F24G0116, 33F24G0220, 33F24G0645, 33F24G0646, 33F24G0680, 33F24H0064, 33F24J0013, 33F24J0457, 33F24K0033, 33F24M0004,33F24M0052, 33F24M0070, 33F24M0103,33F24M0146,33F25A0084, 33F25A0335, 33F25A0346, 33F25A0362, 33F25A0397, 33F25B0080, 33F25B0307, 33F25B0414, 33F25C0058, 33F25C0097, 33F25C0494, 33F25C0575, 33F25D0027, 33F25D0083, 33F25D0102, 33F25D0296, 33F25D0703, 33F25F0293, 33F25F0398, 33F25G0493, 33F25H0322, 33F25H0842, 33F25J0037, 33F25J0767, 33F25K0276, 33F25L0154, 33F25L0169, 33F25L0218, 33F26A1264, 33F26A1290, 33F26A1313, 33F26B0291, 33F24C0728, 33F24C0729, 33F24E0699, 33F24G0596, 33F24H0057, 33F24J0350, 33F24J0458, 33F24K0615, 33F24M0126, 33F25A0338, 33F25B0039, 33F25B0131, 33F25D0192, 33F25D0281, 33F25E1109, 33F25F0496, 33F25J0764, 33F26B0054, 33F23M0173; AK-04020-C/60801902121549, 10801902193275, 10801902121551/33F24G0050, 33F24G0595, 33F24G0619, 33F24G0681, 33F24H0060, 33F24H0085, 33F24H0244, 33F24J0421, 33F24J0471, 33F24L0074, 33F24L0517, 33F24M0051, 33F24M0102, 33F24M0145,33F25A0354,33F25B0013, 33F25B0079, 33F25B0130, 33F25B0279, 33F25C0096, 33F25C0411, 33F25C0523, 33F25C0595, 33F25D0014, 33F25D0082, 33F25D0169, 33F25E0404, 33F25E1088, 33F25E1164, 33F25F0430, 33F25J1033, 33F25K0343, 33F25L0175, 33F25M0472, 33F26A0212, 33F26A1275, 33F26B0053, 33F26B0290, 33F23M0171; AK-04120/10801902190922, 10801902193275, 20801902121572/33F24A1254, 33F24B0432, 33F24C0731, 33F24D0440, 33F24E0701, 33F24H0444, 33F24J0006, 33F24K0623, 33F24L0035, 33F24M0127, 33F25A0129, 33F25B0057, 33F25B0328, 33F25E1096, 33F25F0405, 33F25F0522, 33F25G0511, 33F25J1067, 33F26C0419, 33F24C0789; AK-04122/20801902121572, 10801902193275, 10801902121582/33F24G0051, 33F24G0148, 33F24G0682, 33F24K0535, 33F24M0071, 33F25A0092, 33F25A0380, 33F25B0005, 33F25D0108, 33F25J0762, 33F25K0003, 33F24A1009; AK-04220/10801902190946, 10801902193275, 10801902121636/33F24C0733, 33F24E0703, 33F24G0117, 33F24G0223, 33F24G0683, 33F24H0246, 33F24H0414, 33F24J0009, 33F24J0447, 33F24M0003, 33F24M0086, 33F25C0085, 33F25D0171, 33F25G0065, 33F25J0059, 33F26C0392, 33F24A1257; ASK-04020-AH/10801902193275, 10801902114898/33F24L0219, 33F24L0398, 33F24L0950, 33F25B0174, 33F25C0436, 33F25D0332, 33F25D0648, 33F25E0848, 33F25H0647, 33F25J0350, 33F26C0572, 33F24G0403; ASK-04020-ATH/10801902193275, 10801902193237, 10801902205916/33F24J0553, 33F24K0167, 33F24L0777, 33F25C0133, 33F25C0982, 33F25E0964, 33F25G0106, 33F25G0670, 33F25H0063, 33F25H0727, 33F25L0242, 33F25L0452, 33F25M0947, 33F26B0583, 33F24D0856; ASK-04020-AU2/10801902205916, 10801902193275, 10801902117660/33F24E0645, 33F24F1044, 33F24K0365, 33F24L1020, 33F25A0230, 33F25C0225, 33F25D0333, 33F25E0523, 33F25E0849, 33F25H0474, 33F25J0199, 33F25L0120, 33F25M0208, 33F26A1419, 33F26B0449, 33F26C0030, 33F24A0814; ASK-04020-BHS/10801902193275, 30801902144578, 10801902211429/33F25A0231, 33F25D0589, 33F25E0850, 33F25F0095, 33F25G0320, 33F25J0200, 33F26A1514, 33R24D0228, 33S24C0678, 33S24C1077, 33F24D0277; ASK-04020-BIDB2/10801902193275/33F24K0168, 33F25A0508, 33F25C0134, 33F25C0835, 33F25E0121, 33F25G0107, 33F25H0065, 33F25H0728, 33F25J0669, 33F25K0399, 33F25L0429, 33F25M0929, 33F24J0365; ASK-04020-CCD1/10801902193275/33F24J0289, 33F24J0556, 33F24L0641, 33F25A0510, 33F25C0772, 33F25E0123, 33F25G0108, 33F25H0730, 33F25M0874, 33F24G0282; ASK-04020-CR/10801902193275, 10801902206814/33F24K0169, 33F24L0679, 33F25A0511, 33F25C0785, 33F25E0124, 33F25E0969, 33F25G0109, 33F25G0669, 33F25H0067, 33F25H0731, 33F25J0868, 33F25L0241, 33F25M0881, 33F26B0523, 33F24G0407; ASK-04020-EUH2/10801902193275, 10801902213379, 10801902193244/33F24J0290, 33F24J0557, 33F24L0753, 33F25A0512, 33F25C0930, 33F25E0125, 33F25H0068, 33F25J0869, 33F25M0894, 33F26B0236, 33F23H0888; ASK-04020-FAM1/10801902193275/ 33F24H0374, 33F24J0181, 33F24L0734, 33F25C0135, 33F25C0781, 33F25E0126, 33F25E0970, 33F25J0502, 33F24G0408; ASK-04020-FMC/10801902193275, 10801902121384/33F24J0558, 33F24K0171, 33F25A0513, 33F25C0773, 33F25E0127, 33F25E0971, 33F25H0069, 33F25J0870, 33F25L0388, 33F25M0892, 33F24A0828; ASK-04020-KSF2/10801902193275/33F25A0516, 33F25C0851, 33F25E0132, 33F25H0075, 33F25J0876, 33F25M0906, 33F24K0178; ASK-04020-LHC2/10801902193275, 10801902225525/33F24L0716, 33F25A0517, 33F25C0734, 33F25E0133, 33F25J0503, 33F25L0491, 33F25M0922, 33F26C0672; ASK-04020-LHC3/10801902193275, 10801902225525/33F24L0716, 33F25A0517, 33F25C0734, 33F25E0133, 33F25J0503, 33F25L0491, 33F25M0922, 33F26C0672, 33F24L0653; ASK-04020-LM/10801902193275/33F25B0690, 33F25E0977, 33F25H0076, 33F25J0877, 33F25L0422, 33F25M0925, 33F24G0417; ASK-04020-MCH1/10801902193275, 20801902117711/33F24L0920, 33F24A0380; ASK-04020-MIH1/10801902193275/33F24L0744, 33F25A0522, 33F25C0978, 33F25E0138, 33F25H0080, 33F25J0879, 33F26A0996, 33F25A0442; ASK-04020-NWMX/10801902193275/33F24K0186, 33F25J0882, 33F25L0363, 33F25M0872, 33F24G0423; ASK-04020-PHP/10801902193275, 10801902138498/33F24K0187, 33F25A0148, 33F25C0401, 33F25D0283, 33F25E1145, 33F25J1027, 33F24C0164; ASK-04020-RIHM/10801902193275/33F24L0243, 33F24L1034, 33F25B0177, 33F25C0256, 33F25D0462, 33F25E0525, 33F25E0773, 33F25G0317, 33F25H0645, 33F25J0351, 33F26A1408, 33F24M0095; ASK-04020-RMC1/10801902193275/33F25J0509, 33F25L0464, 33F24L0747; ASK-04020-RU/10801902193275/33F25A0524, 33F25C0807, 33F25E0143, 33F25G0112, 33F25J0510, 33F25M0863, 33F24G0427; ASK-04020-SE/10801902193275, 10801902213263, 10801902138757/33F24L0611, 33F25A0525, 33F25C0849, 33F25E0144, 33F25E0984, 33F25J0511, 33F26B0999, 33F24E0433; ASK-04020-SHM/10801902193275/33F24G0428, 33F24J0576, 33F24K0190, 33F24L0684, 33F25A0526, 33F25C0971, 33F25E0145, 33F25G0113, 33F25J0512, 33F25L0378, 33F25M0883, 33F25C0143; ASK-04020-SRMC1/10801902193275, 10801902117837/33F24J0296, 33F24K0192, 33F24L0710, 33F25C0144, 33F25C0820, 33F25E0146, 33F25H0086, 33F25J0884, 33F25M0842, 33F24A0868; ASK-04020-UCL1/10801902193275, 10801902144550/33F24K0412, 33F24L1081, 33F25A0233, 33F25C0257, 33F25D0393, 33F25E0774, 33F25G0360, 33F25J0201, 33F26B0160, 33F24G0178; ASK-04020-UMI/10801902193275, 10801902145571/33F24L1123, 33F24E0726; ASK-04020-UN/10801902145571, 10801902193275, 60801902117849/33F24K0021, 33F24L0533, 33F24M0053, 33F24M0107, 33F25A0089, 33F25B0016, 33F25B0092, 33F25B0314, 33F25D0015, 33F25D0113, 33F25D0172, 33F25E1146, 33F25H0797, 33F25K0230, 33F26B0090, 33F26B0262, 33F24A0373; ASK-04020-UNC/60801902117849, 10801902193275, 10801902143782/33F24A1035, 33F24B0270, 33F24C0170, 33F24G0432, 33F24J0297, 33F24J0577, 33F24L0799, 33F25A0527, 33F25C0145, 33F25C0994, 33F25E0147, 33F25H0088, 33F25J0513, 33F25L0359, 33F25M0868, 33F26A0993, 33F26B0975, 33F24F0461; ASK-04020-UNC1/10801902193275, 10801902143782, 10801902117851/33F24G0286, 33F24J0298, 33F24K0194, 33F24L0806, 33F25C0146, 33F25E0148, 33F25H0089, 33F25J0514, 33F25L0469, 33F25M0959, 33F26C0599, 33F24A0255; ASK-04220-PSU/10801902193275/33F25A0152, 33F25H0737, 33F24K0495; ASK-04220-UCL1/10801902193275, 10801902159127, 10801902143805/33F24L0290, 33F25A0206, 33F25C0226, 33F25D0463, 33F25E0669, 33F25G0351, 33F25H0428, 33F25J0352, 33F26B0153, 33F24F0619; NA-04020-S1A/10801902193275, 10801902139396/33F25A0600, 33F25C0195, 33F25C0786, 33F25E0270, 33F25E1050, 33F25G0152, 33F25H0177, 33F25H0759, 33F25J0633, 33F25K0404, 33F25L0472, 33F25M0962, 33F26B0595, 33F24J0683; ASK-04550-JMC1/10801902193275, 10801902130836/33F25C0837, 33F25E0175, 33F25E0997, 33F25L0146, 33F24F0685; ASK-04001-BW2/10801902193275, 10801902221602/33F25A0500, 33F25E0110, 33F25H0057, 33F25J0496, 33F25L0360, 33F26A0994, 33S23M0157, 33F25A0226; ASK-04001-WUH1/10801902193275, 10801902220834, 10801902119268/33F24J0549, 33F24K0162, 33F24L0685, 33F25H0061, 33F25J0864, 33F26B0683, 33F26B1021, 33F24A0078; ASK-04510-HUM/10801902115048/33F24C0956, 33F24D0699, 33F24E0647, 33F24F0911, 33F24L0885
Other Recalls from ARROW INTERNATIONAL, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2388-2026 | Class I | Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 F... | Apr 21, 2026 |
| Z-2371-2026 | Class I | Description/REF: EPIDURAL CATHETER KIT: 19 GA ... | Apr 21, 2026 |
| Z-2367-2026 | Class I | Description/REF: AGBA PICC G4 Stylet: 3L 6FR x... | Apr 21, 2026 |
| Z-2386-2026 | Class I | Description/REF: PARACENTESIS KIT/ASK-00376-JHH | Apr 21, 2026 |
| Z-2379-2026 | Class I | Description/REF: PI JACC KIT: 2L 5.5 FR X 15 CM... | Apr 21, 2026 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately, you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.