Urgent site urgencyFDA Class I

Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-VFI, ACS-15232-VFI, ACS-15272-VFI, CS-15192-VFI, CS-15192-VFIE, CS-15232-VFI, CS-15232-VFIE, CS-15272

16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.

Agency: FDA Device
Recall date: Apr 10, 2026
Status: Ongoing
Company: ARROW INTERNATIONAL, LLC

1. What product was recalled?

Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I

Quantity: 285

Code or lot text: REF/UDI-DI/Lot: CS-15242-I/ 30801902195280/33F23G0536; CS-15282-I/30801902195532/33F23C0877, 33F24A0281, 33F24H0041; CS-15322-I/30801902197451/33F23G0545

LOT: 33F24A0281
LOT: 33F24H0041
LOT: CS-15282-I/30801902195532/33F23C0877
LOT: CS-15322-I/30801902197451/33F23G0545
LOT: REF/UDI-DI/Lot: CS-15242-I/ 30801902195280/33F23G0536
RECALL-NUMBER: Z-2156-2026

Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-VFI, ACS-15232-VFI, ACS-15272-VFI, CS-15192-VFI, CS-15192-VFIE, CS-15232-VFI, CS-15232-VFIE, CS-15272

Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-VFI, ACS-15232-VFI, ACS-15272-VFI, CS-15192-VFI, CS-15192-VFIE, CS-15232-VFI, CS-15232-VFIE, CS-15272-VFI, CS-15272-VFIE, CS-15312-VFI, CS-15312-VFIE, CS-15422-VFI, CS-15422-VFIE, CS-15552-VFI, CS-15552-VFIE; Arrow-Clark VectorFlow Antegrade Hemodialysis Catheter with Arrow Simplicity Micro-Introducer: REF: CS-15192-VFIM, CS-15232-VFIM, CS-15272-VFIM; Arrow-Clark VectorFlow Retrograde Chronic Hemodialysis Catheter, REF: ACS-15192-VF, ACS-15232-VF, ACS-15272-VF, ACS-15552-VF, CS-15192-VF, CS-15192-VFE, CS-15232-VF, CS-15232-VFE, CS-15272-VF, CS-15272-VFE, CS-15312-VF, CS-15312-VFE, CS-15422-VF, CS-15422-VFE, CS-15552-VF, CS-15552-VFE; Arrow-Clark VectorFlow Retrograde Hemodialysis Catheter with Arrow Simplicity Micro-Introducer: CS-15192-VFM, CS-15232-VFM, CS-15272-VFM

Quantity: 92,827

Code or lot text: REF/UDI-DI/Lots: ACS-15192-VFI/ 10801902126709/33F23G0040, 33F25C0689; ACS-15232-VFI/10801902126723/33F23G0045, 33F25C0678; ACS-15272-VFI/ 10801902126747/33F24G0638; CS-15192-VFI/10801902127188, 10801902193572/33F23E0579, 33F23G0042, 33F23K0170, 33F23L0933, 33F24E0271, 33F24G0166, 33F24J0086, 33F24L0064, 33F24M0224, 33F25C0652, 33F25D0052, 33F25D0700, 33F25E1081, 33F25F0015, 33F25F0388, 33F25G0702, 33F25H0785; CS-15192-VFIE/10801902199659/33F23D0853, 33F23E0773, 33F23G0044, 33F23G0532, 33F23H0611, 33F23K0169,33F23K1105,33F23L0934, 33F24A0912, 33F24A0913, 33F24C0058, 33F24D1001, 33F24G0167,33F24G0187, 33F24J0030, 33F24J0032, 33F24J0339, 33F24J0381, 33F24K0659, 33F24L0058, 33F24L0511, 33F24M0155, 33F24M0215, 33F24M0265, 33F25A0143, 33F25A0407, 33F25B0259, 33F25C0037, 33F25D0285, 33F25D0738, 33F25F0060, 33F25G0635; CS-15232-VFI/10801902194463/33F23C0864, 33F23E0578, 33F23E0832, 33F23G0535, 33F23G0840, 33F23H0612, 33F23K0144, 33F24A0914, 33F24C0079, 33F24E0269, 33F24J0042, 33F25B0256, 33F25C0014, 33F25C0709, 33F25C0650, 33F25E1085, 33F25E1130, 33F25F0009, 33F25G0023, 33F25G0450, 33F25H0341, 33F25J1014; CS-15232-VFIE/10801902195149/33F23D0855, 33F23E0774, 33F23G0047, 33F23G0048, 33F23G0049, 33F23K0145, 33F23K0175, 33F23L0938, 33F24A0915, 33F24C0069, 33F24G0169, 33F24J0026, 33F24J0027, 33F24J0028, 33F24J0084, 33F24K0700, 33F24L0178, 33F24M0005, 33F24M0214, 33F24M0219, 33F25C0646, 33F25C0665, 33F25D0097, 33F25E0358, 33F25E0434, 33F25F0012, 33F25F0275, 33F25F0328, 33F25G0069, 33F25H0293, 33F25H0822, 33F25K0235; CS-15272-VFI/10801902193640, 10801902127362/33F23E0871, 33F23F0742, 33F23H0981, 33F23K0181, 33F24A0306, 33F24C0084, 33F24J0062, 33F25D0098, 33F25E0307, 33F25E0332, 33F25E0354, 33F25F0058, 33F25F0245, 33F25J0659; CS-15272-VFIE/10801902195255/33F23E0886, 33F23G0537, 33F23H0982, 33F23K0180, 33F23L0946, 33F24A0922, 33F24C0065, 33F24D1011, 33F24E0686, 33F24E0805, 33F24K0508, 33F24M0223, 33F25A0410, 33F25C0009, 33F25G0717; CS-15312-VFI/10801902197778/33F23G0543, 33F23L0953, 33F24D1007, 33F24E0810, 33F24J0048, 33F25C0039, 33F25D0218, 33F25E0470, 33F25J0021; CS-15312-VFIE/10801902195491/33F23K0183, 33F23L0954, 33F24A0923, 33F24D1013, 33F25A0403, 33F25F0534, 33F25G0722; CS-15422-VFI/10801902193664/33F23G0549, 33F24E0815, 33F25E1074; CS-15422-VFIE/10801902197440/33F23G0550, 33F23K0178, 33F23L0958, 33F24A0919, 33F24C0073, 33F24E0816, 33F25F0303; CS-15552-VFI/10801902193671/33F23K0184, 33F24J0076, 33F25E1075; CS-15552-VFIE/10801902195163/33F23E0865, 33F23F0743, 33F24D0972, 33F24E0819, 33F24G0098, 33F24K0656, 33F25A0032; CS-15192-VFIM/10801902193589/33F24E0792, 33F25C0676, 33F25L0035; CS-15232-VFIM/10801902193619/33F23C0879, 33F23L0939, 33F24A0304, 33F24E0798, 33F24J0047; CS-15272-VFIM/10801902197761/33F23H1027; ACS-15192-VF/10801902126693/33F24G0637; ACS-15232-VF/10801902126716/33F23H1016; ACS-15272-VF/10801902126730/33F23H1024; ACS-15552-VF/10801902126792/33F23H1021; CS-15192-VF/20801902193593/33F23K0186, 33F23L0931, 33F24C0082, 33F24E0788, 33F24J0054, 33F24M0162, 33F24M0230, 33F25D0271; CS-15192-VFE/10801902195460/33F23E0776, 33F23F0728, 33F23G0531, 33F24A0917, 33F24C0063, 33F24D1003, 33F24E0789, 33F24J0039, 33F24L0069, 33F24M0156, 33F24M0159, 33F25C0683, 33F25D0107, 33F25D0220, 33F25E0343, 33F25F0273, 33F25F0462, 33F25G0444, 33F25H0820, 33F25K0384; CS-15232-VF/10801902193626/33F23C0873, 33F23J0546, 33F24A0294, 33F24C0071, 33R24G0168, 33F24J0044, 33F25D0089, 33F25E0333, 33F25E0427, 33F25E1095, 33F25F0404, 33F25H0294, 33F25J1009; CS-15232-VFE/10801902195132/33F23E0775, 33F23F0720, 33F23K0176, 33F23K0194, 33F23L0937, 33F24A0927, 33F24C0059, 33F24D1010, 33F24E0270, 33F24E0796, 33F24G0045, 33F24J0035, 33F24J0083, 33F24L0171, 33F24M0216, 33F25A0004, 33F25A0083, 33F25C0023, 33F25C0659, 33F25D0106, 33F25D0219, 33F25D0726, 33F25E0478, 33F25E1105, 33F25F0298, 33F25J1056, 33F25K0335, 33F25L0011; CS-15272-VF/10801902193657/33F23C0880, 33F23F0740, 33F23L0944, 33F24C0081, 33F24E0804, 33F24J0051, 33F24J0686, 33F24M0228, 33F25C0668, 33F25E0337, 33F25F0403, 33F25J0590; CS-15272-VFE/10801902195248/33F23E0777, 33F23F0732, 33F23H0980, 33F23K0172, 33F23L0945, 33F24A0918, 33F24C0064, 33F24H0044, 33F24H0255, 33F24M0237, 33F25C0049, 33F25E0349, 33F25E1132, 33F25G0637; CS-15312-VF/10801902127447/33F24G0060, 33F25D0216; CS-15312-VFE/10801902195484/33F23F0734, 33F23G0542, 33F23L0952, 33F24A0925, 33F24C0076, 33F24J0053, 33F24M0225, 33F25A0033, 33F25C0667, 33F25E0320, 33F25E0469, 33F25G0603; CS-15422-VF/10801902128666/33F23H1020, 33F25G0734; CS-15422-VFE/10801902197341/33F23G0548, 33F23H0986, 33F23L0957, 33F24A0929, 33F24J0483, 33F24M0229, 33F25C0681, 33F25E0440, 33F25F0250, 33F25G0484; CS-15552-VF/10801902128703/33F23H1012, 33F25C0674, 33F25J0588; CS-15552-VFE/10801902195156/33F23D0868, 33F23G0261, 33F23G0551, 33F23K0173, 33F24A0928, 33F24D1014, 33F24E0818, 33F24J0059, 33F24K0511, 33F25C0670, 33F25E0471, 33F25F0455, 33F25G0447; CS-15192-VFM/10801902193602/33F23K0189, 33F24C0078, 33F24J0049, 33F24M0243, 33F25C0672, 33F25E1077, 33F25F0418; CS-15232-VFM/10801902193633/33F23J0547, 33F24A0289, 33F24C0077, 33F24E0799, 33F24J0045, 33F24J0093, 33F25A0026, 33F25C0050, 33F25E0348, 33F25K0348; CS-15272-VFM/10801902127393/33F25C0687

LOT: 10801902127362/33F23E0871
LOT: 10801902193572/33F23E0579
LOT: 33F23E0578
LOT: 33F23E0773
LOT: 33F23E0774
LOT: 33F23E0832
LOT: 33F23F0720
LOT: 33F23F0728
LOT: 33F23F0732
LOT: 33F23F0740
LOT: 33F23F0742
LOT: 33F23F0743
LOT: 33F23G0042
LOT: 33F23G0044
LOT: 33F23G0047
LOT: 33F23G0048
LOT: 33F23G0049
LOT: 33F23G0261
LOT: 33F23G0531
LOT: 33F23G0532
LOT: 33F23G0535
LOT: 33F23G0537
LOT: 33F23G0542
LOT: 33F23G0551
LOT: 33F23G0840
LOT: 33F23H0611
LOT: 33F23H0612
LOT: 33F23H0980
LOT: 33F23H0981
LOT: 33F23H0982
LOT: 33F23H0986
LOT: 33F23J0546
LOT: 33F23K0144
LOT: 33F23K0145
LOT: 33F23K0169
LOT: 33F23K0170
LOT: 33F23K0172
LOT: 33F23K0173
LOT: 33F23K0175
LOT: 33F23K0176
LOT: 33F23K0178
LOT: 33F23K0180
LOT: 33F23K0181
LOT: 33F23K0194
LOT: 33F23K1105
LOT: 33F23L0931
LOT: 33F23L0933
LOT: 33F23L0934
LOT: 33F23L0937
LOT: 33F23L0938
LOT: 33F23L0939
LOT: 33F23L0944
LOT: 33F23L0945
LOT: 33F23L0946
LOT: 33F23L0952
LOT: 33F23L0953
LOT: 33F23L0954
LOT: 33F23L0957
LOT: 33F23L0958
LOT: 33F24A0289
LOT: 33F24A0294
LOT: 33F24A0304
LOT: 33F24A0306
LOT: 33F24A0912
LOT: 33F24A0913
LOT: 33F24A0914
LOT: 33F24A0915
LOT: 33F24A0917
LOT: 33F24A0918
LOT: 33F24A0919
LOT: 33F24A0922
LOT: 33F24A0923
LOT: 33F24A0925
LOT: 33F24A0927
LOT: 33F24A0928
LOT: 33F24A0929
LOT: 33F24C0058
LOT: 33F24C0059
LOT: 33F24C0063
LOT: 33F24C0064
LOT: 33F24C0065
LOT: 33F24C0069
LOT: 33F24C0071
LOT: 33F24C0073
LOT: 33F24C0076
LOT: 33F24C0077
LOT: 33F24C0078
LOT: 33F24C0079
LOT: 33F24C0081
LOT: 33F24C0082
LOT: 33F24C0084
LOT: 33F24D0972
LOT: 33F24D1001
LOT: 33F24D1003
LOT: 33F24D1007
LOT: 33F24D1010
LOT: 33F24D1011
LOT: 33F24D1013
LOT: 33F24D1014
LOT: 33F24E0269
LOT: 33F24E0270
LOT: 33F24E0271
LOT: 33F24E0686
LOT: 33F24E0788
LOT: 33F24E0789
LOT: 33F24E0796
LOT: 33F24E0798
LOT: 33F24E0799
LOT: 33F24E0804
LOT: 33F24E0805
LOT: 33F24E0810
LOT: 33F24E0815
LOT: 33F24E0816
LOT: 33F24E0818
LOT: 33F24E0819
LOT: 33F24G0045
LOT: 33F24G0098
LOT: 33F24G0166
LOT: 33F24G0167
LOT: 33F24G0169
LOT: 33F24G0187
LOT: 33F24H0044
LOT: 33F24H0255
LOT: 33F24J0026
LOT: 33F24J0027
LOT: 33F24J0028
LOT: 33F24J0030
LOT: 33F24J0032
LOT: 33F24J0035
LOT: 33F24J0039
LOT: 33F24J0042
LOT: 33F24J0044
LOT: 33F24J0045
LOT: 33F24J0047
LOT: 33F24J0048
LOT: 33F24J0049
LOT: 33F24J0051
LOT: 33F24J0053
LOT: 33F24J0054
LOT: 33F24J0059
LOT: 33F24J0062
LOT: 33F24J0076
LOT: 33F24J0083
LOT: 33F24J0084
LOT: 33F24J0086
LOT: 33F24J0093
LOT: 33F24J0339
LOT: 33F24J0381
LOT: 33F24J0483
LOT: 33F24J0686
LOT: 33F24K0508
LOT: 33F24K0511
LOT: 33F24K0656
LOT: 33F24K0659
LOT: 33F24K0700
LOT: 33F24L0058
LOT: 33F24L0064
LOT: 33F24L0069
LOT: 33F24L0171
LOT: 33F24L0178
LOT: 33F24L0511
LOT: 33F24M0005
LOT: 33F24M0155
LOT: 33F24M0156
LOT: 33F24M0159
LOT: 33F24M0162
LOT: 33F24M0214
LOT: 33F24M0215
LOT: 33F24M0216
LOT: 33F24M0219
LOT: 33F24M0223
LOT: 33F24M0224
LOT: 33F24M0225
LOT: 33F24M0228
LOT: 33F24M0229
LOT: 33F24M0230
LOT: 33F24M0237
LOT: 33F24M0243
LOT: 33F24M0265
LOT: 33F25A0004
LOT: 33F25A0026
LOT: 33F25A0032
LOT: 33F25A0033
LOT: 33F25A0083
LOT: 33F25A0143
LOT: 33F25A0403
LOT: 33F25A0407
LOT: 33F25A0410
LOT: 33F25B0256
LOT: 33F25B0259
LOT: 33F25C0009
LOT: 33F25C0014
LOT: 33F25C0023
LOT: 33F25C0037
LOT: 33F25C0039
LOT: 33F25C0049
LOT: 33F25C0050
LOT: 33F25C0646
LOT: 33F25C0650
LOT: 33F25C0652
LOT: 33F25C0659
LOT: 33F25C0665
LOT: 33F25C0667
LOT: 33F25C0668
LOT: 33F25C0670
LOT: 33F25C0672
LOT: 33F25C0674
LOT: 33F25C0676
LOT: 33F25C0678
LOT: 33F25C0681
LOT: 33F25C0683
LOT: 33F25C0689
LOT: 33F25C0709
LOT: 33F25D0052
LOT: 33F25D0089
LOT: 33F25D0097
LOT: 33F25D0098
LOT: 33F25D0106
LOT: 33F25D0107
LOT: 33F25D0216
LOT: 33F25D0218
LOT: 33F25D0219
LOT: 33F25D0220
LOT: 33F25D0271
LOT: 33F25D0285
LOT: 33F25D0700
LOT: 33F25D0726
LOT: 33F25D0738
LOT: 33F25E0307
LOT: 33F25E0320
LOT: 33F25E0332
LOT: 33F25E0333
LOT: 33F25E0337
LOT: 33F25E0343
LOT: 33F25E0348
LOT: 33F25E0349
LOT: 33F25E0354
LOT: 33F25E0358
LOT: 33F25E0427
LOT: 33F25E0434
LOT: 33F25E0440
LOT: 33F25E0469
LOT: 33F25E0470
LOT: 33F25E0471
LOT: 33F25E0478
LOT: 33F25E1074
LOT: 33F25E1075
LOT: 33F25E1077
LOT: 33F25E1081
LOT: 33F25E1085
LOT: 33F25E1095
LOT: 33F25E1105
LOT: 33F25E1130
LOT: 33F25E1132
LOT: 33F25F0009
LOT: 33F25F0012
LOT: 33F25F0015
LOT: 33F25F0058
LOT: 33F25F0060
LOT: 33F25F0245
LOT: 33F25F0250
LOT: 33F25F0273
LOT: 33F25F0275
LOT: 33F25F0298
LOT: 33F25F0303
LOT: 33F25F0328
LOT: 33F25F0388
LOT: 33F25F0403
LOT: 33F25F0404
LOT: 33F25F0418
LOT: 33F25F0455
LOT: 33F25F0462
LOT: 33F25F0534
LOT: 33F25G0023
LOT: 33F25G0069
LOT: 33F25G0444
LOT: 33F25G0447
LOT: 33F25G0450
LOT: 33F25G0484
LOT: 33F25G0603
LOT: 33F25G0635
LOT: 33F25G0637
LOT: 33F25G0702
LOT: 33F25G0717
LOT: 33F25G0722
LOT: 33F25G0734
LOT: 33F25H0293
LOT: 33F25H0294
LOT: 33F25H0341
LOT: 33F25H0785
LOT: 33F25H0820
LOT: 33F25H0822
LOT: 33F25J0021
LOT: 33F25J0588
LOT: 33F25J0590
LOT: 33F25J0659
LOT: 33F25J1009
LOT: 33F25J1014
LOT: 33F25J1056
LOT: 33F25K0235
LOT: 33F25K0335
LOT: 33F25K0348
LOT: 33F25K0384
LOT: 33F25L0011
LOT: 33F25L0035
LOT: 33R24G0168
LOT: ACS-15192-VF/10801902126693/33F24G0637
LOT: ACS-15232-VF/10801902126716/33F23H1016
LOT: ACS-15232-VFI/10801902126723/33F23G0045
LOT: ACS-15272-VF/10801902126730/33F23H1024
LOT: ACS-15272-VFI/ 10801902126747/33F24G0638
LOT: ACS-15552-VF/10801902126792/33F23H1021
LOT: CS-15192-VF/20801902193593/33F23K0186
LOT: CS-15192-VFE/10801902195460/33F23E0776
LOT: CS-15192-VFI/10801902127188
LOT: CS-15192-VFIE/10801902199659/33F23D0853
LOT: CS-15192-VFIM/10801902193589/33F24E0792
LOT: CS-15192-VFM/10801902193602/33F23K0189
LOT: CS-15232-VF/10801902193626/33F23C0873
LOT: CS-15232-VFE/10801902195132/33F23E0775
LOT: CS-15232-VFI/10801902194463/33F23C0864
LOT: CS-15232-VFIE/10801902195149/33F23D0855
LOT: CS-15232-VFIM/10801902193619/33F23C0879
LOT: CS-15232-VFM/10801902193633/33F23J0547
LOT: CS-15272-VF/10801902193657/33F23C0880
LOT: CS-15272-VFE/10801902195248/33F23E0777
LOT: CS-15272-VFI/10801902193640
LOT: CS-15272-VFIE/10801902195255/33F23E0886
LOT: CS-15272-VFIM/10801902197761/33F23H1027
LOT: CS-15272-VFM/10801902127393/33F25C0687
LOT: CS-15312-VF/10801902127447/33F24G0060
LOT: CS-15312-VFE/10801902195484/33F23F0734
LOT: CS-15312-VFI/10801902197778/33F23G0543
LOT: CS-15312-VFIE/10801902195491/33F23K0183
LOT: CS-15422-VF/10801902128666/33F23H1020
LOT: CS-15422-VFE/10801902197341/33F23G0548
LOT: CS-15422-VFI/10801902193664/33F23G0549
LOT: CS-15422-VFIE/10801902197440/33F23G0550
LOT: CS-15552-VF/10801902128703/33F23H1012
LOT: CS-15552-VFE/10801902195156/33F23D0868
LOT: CS-15552-VFI/10801902193671/33F23K0184
LOT: CS-15552-VFIE/10801902195163/33F23E0865
LOT: REF/UDI-DI/Lots: ACS-15192-VFI/ 10801902126709/33F23G0040
RECALL-NUMBER: Z-2157-2026

Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-15322-VSP, CS-15362-VSP, CS-15552-VSP, CSD-15242-SP, CSD-15282-SP

Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-15322-VSP, CS-15362-VSP, CS-15552-VSP, CSD-15242-SP, CSD-15282-SP; Cannon II Plus Hemodialysis Catheter with Arrow Simplicity Micro-Introducer, REF: CS-15242-SPM, CS-15282-SPM, CS-15322-SPM, CS-15362-SPM

Quantity: 34,568

Code or lot text: REF/UDI-DI/Lots: CS-15242-VSP/30801902195273/33F23C0870, 33F23D0857, 33F23F0719, 33F23K0182, 33F24A0265, 33F24C0062, 33F24D1000, 33F24D1039, 33F24E0803, 33F24H0038, 33F24H0261, 33F24K0505, 33F24M0039, 33F24M0218, 33F25A0141, 33F25C0657, 33F25D0125, 33F25E0305, 33F25E0429, 33F25E0430, 33F25E1131, 33F25F0042, 33F25G0070, 33F25H0295, 33F25H0366, 33F25H0674, 33F25J1015; CS-15282-VSP/30801902195518/33F23C0866, 33F23D0854, 33F23E0572, 33F23F0594, 33F23G0540, 33F23J0544, 33F23K0174, 33F23L0950, 33F24B0010, 33F24C0060, 33F24D0993, 33F24D1040, 33F24E0268, 33F24E0809, 33F24F0155, 33F24J0037, 33F24M0007, 33F24M0040, 33F24M0165, 33F24M0217, 33F25A0406, 33F25B0269, 33F25C0021, 33F25C0045, 33F25C0642, 33F25D0013, 33F25D0713, 33F25F0249, 33F25H0296, 33F25J0051; CS-15322-VSP/20801902195184/33F23C0869, 33F23D0862, 33F23F0723, 33F23H0985, 33F24A0272, 33F24C0066, 33F24E0813, 33F24G0170, 33F24G0185, 33F24H0256, 33F24J0040, 33F24L0183, 33F24M0222, 33F25A0426, 33F25C0022, 33F25C0593, 33F25E1082, 33F25G0024, 33F25H0297; CS-15362-VSP/30801902195525/33F23C0875, 33F23G0546, 33F23K0195, 33F24E0186, 33F24H0039, 33F24L0201, 33F24M0235, 33F25C0647, 33F25E0326, 33F25G0058, 33F25J0043; CS-15552-VSP/30801902195198/33F23G0552, 33F23H0987, 33F23L0961, 33F24C0070, 33F24E0820, 33F24H0257, 33F24L0068, 33F24M0227, 33F25C0654, 33F25E0432; CSD-15242-SP/20801902096610/33F24A0303, 33F25C0688; CSD-15282-SP/20801902096634/33F23K1087, 33F24A0297; CS-15242-SPM/10801902193527/33F23D0867, 33F23K0192, 33F24A0288, 33F24E0802, 33F24M0244, 33F25C0669, 33F25E0338, 33F25G0586; CS-15282-SPM/10801902193688/33F23C0872, 33F23D0864, 33F23G0539, 33F23L0949, 33F24A0278, 33F24C0075, 33F24E0808, 33F24H0254, 33F24J0036, 33F24L1166, 33F24M0233, 33F25A0413, 33F25C0666, 33F25H0824; CS-15322-SPM/30801902193538/33F23D0865, 33F23H1010, 33F23L0955, 33F24E0812, 33F25C0682, 33F25E0335; CS-15362-SPM/20801902193548/33F24G0062

LOT: 33F23D0854
LOT: 33F23D0857
LOT: 33F23D0862
LOT: 33F23D0864
LOT: 33F23E0572
LOT: 33F23F0594
LOT: 33F23F0719
LOT: 33F23F0723
LOT: 33F23G0539
LOT: 33F23G0540
LOT: 33F23G0546
LOT: 33F23H0985
LOT: 33F23H0987
LOT: 33F23H1010
LOT: 33F23J0544
LOT: 33F23K0174
LOT: 33F23K0182
LOT: 33F23K0192
LOT: 33F23K0195
LOT: 33F23L0949
LOT: 33F23L0950
LOT: 33F23L0955
LOT: 33F23L0961
LOT: 33F24A0265
LOT: 33F24A0272
LOT: 33F24A0278
LOT: 33F24A0288
LOT: 33F24A0297
LOT: 33F24B0010
LOT: 33F24C0060
LOT: 33F24C0062
LOT: 33F24C0066
LOT: 33F24C0070
LOT: 33F24C0075
LOT: 33F24D0993
LOT: 33F24D1000
LOT: 33F24D1039
LOT: 33F24D1040
LOT: 33F24E0186
LOT: 33F24E0268
LOT: 33F24E0802
LOT: 33F24E0803
LOT: 33F24E0808
LOT: 33F24E0809
LOT: 33F24E0812
LOT: 33F24E0813
LOT: 33F24E0820
LOT: 33F24F0155
LOT: 33F24G0170
LOT: 33F24G0185
LOT: 33F24H0038
LOT: 33F24H0039
LOT: 33F24H0254
LOT: 33F24H0256
LOT: 33F24H0257
LOT: 33F24H0261
LOT: 33F24J0036
LOT: 33F24J0037
LOT: 33F24J0040
LOT: 33F24K0505
LOT: 33F24L0068
LOT: 33F24L0183
LOT: 33F24L0201
LOT: 33F24L1166
LOT: 33F24M0007
LOT: 33F24M0039
LOT: 33F24M0040
LOT: 33F24M0165
LOT: 33F24M0217
LOT: 33F24M0218
LOT: 33F24M0222
LOT: 33F24M0227
LOT: 33F24M0233
LOT: 33F24M0235
LOT: 33F24M0244
LOT: 33F25A0141
LOT: 33F25A0406
LOT: 33F25A0413
LOT: 33F25A0426
LOT: 33F25B0269
LOT: 33F25C0021
LOT: 33F25C0022
LOT: 33F25C0045
LOT: 33F25C0593
LOT: 33F25C0642
LOT: 33F25C0647
LOT: 33F25C0654
LOT: 33F25C0657
LOT: 33F25C0666
LOT: 33F25C0669
LOT: 33F25C0682
LOT: 33F25C0688
LOT: 33F25D0013
LOT: 33F25D0125
LOT: 33F25D0713
LOT: 33F25E0305
LOT: 33F25E0326
LOT: 33F25E0335
LOT: 33F25E0338
LOT: 33F25E0429
LOT: 33F25E0430
LOT: 33F25E0432
LOT: 33F25E1082
LOT: 33F25E1131
LOT: 33F25F0042
LOT: 33F25F0249
LOT: 33F25G0024
LOT: 33F25G0058
LOT: 33F25G0070
LOT: 33F25G0586
LOT: 33F25H0295
LOT: 33F25H0296
LOT: 33F25H0297
LOT: 33F25H0366
LOT: 33F25H0674
LOT: 33F25H0824
LOT: 33F25J0043
LOT: 33F25J0051
LOT: 33F25J1015
LOT: CS-15242-SPM/10801902193527/33F23D0867
LOT: CS-15282-SPM/10801902193688/33F23C0872
LOT: CS-15282-VSP/30801902195518/33F23C0866
LOT: CS-15322-SPM/30801902193538/33F23D0865
LOT: CS-15322-VSP/20801902195184/33F23C0869
LOT: CS-15362-SPM/20801902193548/33F24G0062
LOT: CS-15362-VSP/30801902195525/33F23C0875
LOT: CS-15552-VSP/30801902195198/33F23G0552
LOT: CSD-15242-SP/20801902096610/33F24A0303
LOT: CSD-15282-SP/20801902096634/33F23K1087
LOT: REF/UDI-DI/Lots: CS-15242-VSP/30801902195273/33F23C0870
RECALL-NUMBER: Z-2158-2026

NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SFX, CS-15192-SFX, CS-15232-SFX, CS-15272-SFX, CS-15312-SFX, CS-15422-SFX, CS-15502-SFX

NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SFX, CS-15192-SFX, CS-15232-SFX, CS-15272-SFX, CS-15312-SFX, CS-15422-SFX, CS-15502-SFX; NextStep Antegrade Hemodialysis Catheter with Arrow Simplicity Micro-Introducer, REF: CS-15192-SFXM, CS-15232-SFXM; NextStep Retrograde Hemodialysis Catheter, REF: AC-15192-X, AC-15232-X, AC-15272-X, CS-15192-X, CS-15232-X, CS-15272-X, CS-15312-X; NextStep Retrograde Hemodialysis Catheter with Arrow Simplicity Micro-Introducer, REF: CS-15192-XM, CS-15232-XM, CS-15272-XM, CS-15312-XM

Quantity: 19,687

Code or lot text: REF/UDI-DI/Lots: AC-15192-SFX/30801902197758/AC-15192-SFX; AC-15232-SFX/00801902095909/33F23H1018; CS-15192-SFX/30801902195297/33F23E0575, 33F23G0530, 33F23K0187, 33F23K1104, 33F23L0929, 33F24A0275, 33F24C0068, 33F24D1012, 33F25C0020, 33F25E1083, 33F25G0636, 33F25H0292, 33F25H0790, 33F25L0038; CS-15232-SFX/30801902195549/33F23E0576, 33F23G0534, 33F23L0936, 33F24A0279, 33F24C0067, 33F24D1006, 33F24E0684, 33F24H0258, 33F24J0033, 33F24J0085, 33F24J0342, 33F24L0056, 33F24M0231, 33F25A0405, 33F25C0036, 33F25C0664, 33F25D0739, 33F25E0433, 33F25G0716, 33F25H0248; CS-15272-SFX/10801902195217/33F23B0321, 33F23D0859, 33F23H0500, 33F23K0177, 33F23L0943, 33F24A0280, 33F24C0083, 33F24H0042, 33F24H0260, 33F24J0022, 33F24J0038, 33F24J0088, 33F24L0177, 33F25C0028, 33F25E1090, 33F25F0301, 33F25F0514; CS-15312-SFX/30801902197529/33F23G0541, 33F23H0984, 33F23L0951, 33F24A0283; CS-15422-SFX/30801902195327/33F23K0179, 33F23L0956, 33F24A0290, 33F24E0814; CS-15502-SFX/30801902195563/33F23L0959, 33F24A0286, 33F24J0060; CS-15192-SFXM/10801902127157/33F25C0015, 33F25E1084; CS-15232-SFXM/10801902127232/33F25C0671; AC-15192-X/ 00801902095879/33F23F0744, 33F24E0784, 33F25D0685; AC-15232-X/00801902095916/33F23H1013, 33F24J0068, 33F25C0675, 33F25J0589; AC-15272-X/00801902095954/33F23H1023; CS-15192-X/30801902195303/33F23C0886, 33F23E0564, 33F23G0263, 33F23G0533, 33F23K0712, 33F23L0935, 33F24E0187, 33F24E0793, 33F24G0171, 33F24J0017, 33F24J0041, 33F25D0701, 33F25E0476, 33F25F0486, 33F25H0783, 33F25H0857; CS-15232-X/30801902195556/33F23C0862, 33F23E0566, 33F23F0722, 33F23K0171, 33F23L0940, 33F24A0916, 33F24C0061, 33F24D1037, 33F24E0800, 33F24J0043, 33F24L0176, 33F25A0028, 33F25C0029, 33F25C0644, 33F25D0096, 33F25E0352, 33F25F0300, 33F25F0513, 33F25E0477, 33F25J0745; CS-15272-X/10801902195224/33F23C0887, 33F23F0731, 33F23H0983, 33F23K0190, 33F23L0947, 33F24E0807, 33F24F0124, 33F24J0018, 33F24J0050, 33F24L0054, 33F24L0063, 33F24M0006, 33F25C0684, 33F25E0342, 33F25F0276, 33F25J0641; CS-15312-X/30801902195310/33F23C0863, 33F23D0858, 33F23G0544; CS-15192-XM/10801902127225/33F25D0711; CS-15232-XM/10801902127300/33F25E0435; CS-15272-XM/10801902127409/33F25C0680, 33F25K0272; CS-15312-XM/10801902127508/33F25E0442

LOT: 33F23D0858
LOT: 33F23D0859
LOT: 33F23E0564
LOT: 33F23E0566
LOT: 33F23F0722
LOT: 33F23F0731
LOT: 33F23G0263
LOT: 33F23G0530
LOT: 33F23G0533
LOT: 33F23G0534
LOT: 33F23G0544
LOT: 33F23H0500
LOT: 33F23H0983
LOT: 33F23H0984
LOT: 33F23K0171
LOT: 33F23K0177
LOT: 33F23K0187
LOT: 33F23K0190
LOT: 33F23K0712
LOT: 33F23K1104
LOT: 33F23L0929
LOT: 33F23L0935
LOT: 33F23L0936
LOT: 33F23L0940
LOT: 33F23L0943
LOT: 33F23L0947
LOT: 33F23L0951
LOT: 33F23L0956
LOT: 33F24A0275
LOT: 33F24A0279
LOT: 33F24A0280
LOT: 33F24A0283
LOT: 33F24A0286
LOT: 33F24A0290
LOT: 33F24A0916
LOT: 33F24C0061
LOT: 33F24C0067
LOT: 33F24C0068
LOT: 33F24C0083
LOT: 33F24D1006
LOT: 33F24D1012
LOT: 33F24D1037
LOT: 33F24E0187
LOT: 33F24E0684
LOT: 33F24E0784
LOT: 33F24E0793
LOT: 33F24E0800
LOT: 33F24E0807
LOT: 33F24E0814
LOT: 33F24F0124
LOT: 33F24G0171
LOT: 33F24H0042
LOT: 33F24H0258
LOT: 33F24H0260
LOT: 33F24J0017
LOT: 33F24J0018
LOT: 33F24J0022
LOT: 33F24J0033
LOT: 33F24J0038
LOT: 33F24J0041
LOT: 33F24J0043
LOT: 33F24J0050
LOT: 33F24J0060
LOT: 33F24J0068
LOT: 33F24J0085
LOT: 33F24J0088
LOT: 33F24J0342
LOT: 33F24L0054
LOT: 33F24L0056
LOT: 33F24L0063
LOT: 33F24L0176
LOT: 33F24L0177
LOT: 33F24M0006
LOT: 33F24M0231
LOT: 33F25A0028
LOT: 33F25A0405
LOT: 33F25C0020
LOT: 33F25C0028
LOT: 33F25C0029
LOT: 33F25C0036
LOT: 33F25C0644
LOT: 33F25C0664
LOT: 33F25C0675
LOT: 33F25C0684
LOT: 33F25D0096
LOT: 33F25D0685
LOT: 33F25D0701
LOT: 33F25D0739
LOT: 33F25E0342
LOT: 33F25E0352
LOT: 33F25E0433
LOT: 33F25E0476
LOT: 33F25E0477
LOT: 33F25E1083
LOT: 33F25E1084
LOT: 33F25E1090
LOT: 33F25F0276
LOT: 33F25F0300
LOT: 33F25F0301
LOT: 33F25F0486
LOT: 33F25F0513
LOT: 33F25F0514
LOT: 33F25G0636
LOT: 33F25G0716
LOT: 33F25H0248
LOT: 33F25H0292
LOT: 33F25H0783
LOT: 33F25H0790
LOT: 33F25H0857
LOT: 33F25J0589
LOT: 33F25J0641
LOT: 33F25J0745
LOT: 33F25K0272
LOT: 33F25L0038
LOT: AC-15192-X/ 00801902095879/33F23F0744
LOT: AC-15232-SFX/00801902095909/33F23H1018
LOT: AC-15232-X/00801902095916/33F23H1013
LOT: AC-15272-X/00801902095954/33F23H1023
LOT: CS-15192-SFX/30801902195297/33F23E0575
LOT: CS-15192-SFXM/10801902127157/33F25C0015
LOT: CS-15192-X/30801902195303/33F23C0886
LOT: CS-15192-XM/10801902127225/33F25D0711
LOT: CS-15232-SFX/30801902195549/33F23E0576
LOT: CS-15232-SFXM/10801902127232/33F25C0671
LOT: CS-15232-X/30801902195556/33F23C0862
LOT: CS-15232-XM/10801902127300/33F25E0435
LOT: CS-15272-SFX/10801902195217/33F23B0321
LOT: CS-15272-X/10801902195224/33F23C0887
LOT: CS-15272-XM/10801902127409/33F25C0680
LOT: CS-15312-SFX/30801902197529/33F23G0541
LOT: CS-15312-X/30801902195310/33F23C0863
LOT: CS-15312-XM/10801902127508/33F25E0442
LOT: CS-15422-SFX/30801902195327/33F23K0179
LOT: CS-15502-SFX/30801902195563/33F23L0959
LOT: REF/UDI-DI/Lots: AC-15192-SFX/30801902197758/AC-15192-SFX
RECALL-NUMBER: Z-2159-2026

2. Is my exact product affected?

Compare every printed identifier. A matching value can indicate that your product is included.

3. What is the hazard?

4. What should I do now?

Follow the FDA recall notice and contact the recalling company for current instructions.

5. Where was it sold or distributed?

Nationwide

View source evidence for state distribution

Alabama: Worldwide distribution: US nationwide and countries of: AE, AL, AR, AT, AU, BE, BG, BS, BR, BW, CA, CH, CL, CN, CO, CZ, DE, EC, EE, ES, FR, GB, GR, GT, HU, ID, IE, IN, IT, JP, KW, KZ, LB, LT, LU, MN, MZ, NA, NL, NO, NP, NZ, PA, PE, PF, PH, PL, PT, QA, RO, RS, RU, SA, SG, SL, SK, SZ, TH, TN, TR, TT, UA, VN, ZA, ZM, and ZW
Arkansas: Worldwide distribution: US nationwide and countries of: AE, AL, AR, AT, AU, BE, BG, BS, BR, BW, CA, CH, CL, CN, CO, CZ, DE, EC, EE, ES, FR, GB, GR, GT, HU, ID, IE, IN, IT, JP, KW, KZ, LB, LT, LU, MN, MZ, NA, NL, NO, NP, NZ, PA, PE, PF, PH, PL, PT, QA, RO, RS, RU, SA, SG, SL, SK, SZ, TH, TN, TR, TT, UA, VN, ZA, ZM, and ZW
California: Worldwide distribution: US nationwide and countries of: AE, AL, AR, AT, AU, BE, BG, BS, BR, BW, CA, CH, CL, CN, CO, CZ, DE, EC, EE, ES, FR, GB, GR, GT, HU, ID, IE, IN, IT, JP, KW, KZ, LB, LT, LU, MN, MZ, NA, NL, NO, NP, NZ, PA, PE, PF, PH, PL, PT, QA, RO, RS, RU, SA, SG, SL, SK, SZ, TH, TN, TR, TT, UA, VN, ZA, ZM, and ZW
Colorado: Worldwide distribution: US nationwide and countries of: AE, AL, AR, AT, AU, BE, BG, BS, BR, BW, CA, CH, CL, CN, CO, CZ, DE, EC, EE, ES, FR, GB, GR, GT, HU, ID, IE, IN, IT, JP, KW, KZ, LB, LT, LU, MN, MZ, NA, NL, NO, NP, NZ, PA, PE, PF, PH, PL, PT, QA, RO, RS, RU, SA, SG, SL, SK, SZ, TH, TN, TR, TT, UA, VN, ZA, ZM, and ZW
Delaware: Worldwide distribution: US nationwide and countries of: AE, AL, AR, AT, AU, BE, BG, BS, BR, BW, CA, CH, CL, CN, CO, CZ, DE, EC, EE, ES, FR, GB, GR, GT, HU, ID, IE, IN, IT, JP, KW, KZ, LB, LT, LU, MN, MZ, NA, NL, NO, NP, NZ, PA, PE, PF, PH, PL, PT, QA, RO, RS, RU, SA, SG, SL, SK, SZ, TH, TN, TR, TT, UA, VN, ZA, ZM, and ZW
Idaho: Worldwide distribution: US nationwide and countries of: AE, AL, AR, AT, AU, BE, BG, BS, BR, BW, CA, CH, CL, CN, CO, CZ, DE, EC, EE, ES, FR, GB, GR, GT, HU, ID, IE, IN, IT, JP, KW, KZ, LB, LT, LU, MN, MZ, NA, NL, NO, NP, NZ, PA, PE, PF, PH, PL, PT, QA, RO, RS, RU, SA, SG, SL, SK, SZ, TH, TN, TR, TT, UA, VN, ZA, ZM, and ZW
Indiana: Worldwide distribution: US nationwide and countries of: AE, AL, AR, AT, AU, BE, BG, BS, BR, BW, CA, CH, CL, CN, CO, CZ, DE, EC, EE, ES, FR, GB, GR, GT, HU, ID, IE, IN, IT, JP, KW, KZ, LB, LT, LU, MN, MZ, NA, NL, NO, NP, NZ, PA, PE, PF, PH, PL, PT, QA, RO, RS, RU, SA, SG, SL, SK, SZ, TH, TN, TR, TT, UA, VN, ZA, ZM, and ZW
Minnesota: Worldwide distribution: US nationwide and countries of: AE, AL, AR, AT, AU, BE, BG, BS, BR, BW, CA, CH, CL, CN, CO, CZ, DE, EC, EE, ES, FR, GB, GR, GT, HU, ID, IE, IN, IT, JP, KW, KZ, LB, LT, LU, MN, MZ, NA, NL, NO, NP, NZ, PA, PE, PF, PH, PL, PT, QA, RO, RS, RU, SA, SG, SL, SK, SZ, TH, TN, TR, TT, UA, VN, ZA, ZM, and ZW
Pennsylvania: Worldwide distribution: US nationwide and countries of: AE, AL, AR, AT, AU, BE, BG, BS, BR, BW, CA, CH, CL, CN, CO, CZ, DE, EC, EE, ES, FR, GB, GR, GT, HU, ID, IE, IN, IT, JP, KW, KZ, LB, LT, LU, MN, MZ, NA, NL, NO, NP, NZ, PA, PE, PF, PH, PL, PT, QA, RO, RS, RU, SA, SG, SL, SK, SZ, TH, TN, TR, TT, UA, VN, ZA, ZM, and ZW
Tennessee: Worldwide distribution: US nationwide and countries of: AE, AL, AR, AT, AU, BE, BG, BS, BR, BW, CA, CH, CL, CN, CO, CZ, DE, EC, EE, ES, FR, GB, GR, GT, HU, ID, IE, IN, IT, JP, KW, KZ, LB, LT, LU, MN, MZ, NA, NL, NO, NP, NZ, PA, PE, PF, PH, PL, PT, QA, RO, RS, RU, SA, SG, SL, SK, SZ, TH, TN, TR, TT, UA, VN, ZA, ZM, and ZW

6. Were injuries or illnesses reported?

No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.

7. What remedy is available?

Follow the FDA recall notice and contact the recalling company for current instructions.

8. Is the recall active or closed?

The source status is Ongoing. The Recall Guy's urgency label is urgent, which is a separate deterministic site label.

9. When was the information checked?

Last checked 10/1/2026, 7:00:04 PM UTC.

2026-08-18T20:33:15.041Zcreated

10. Where is the official source?

Open the official FDA Device source

The Recall Guy normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.