ARROW INTERNATIONAL, LLC: Description/REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1; EPIDURAL CATHETERIZATION KIT: 19 GA/AK-05501; EPIDURAL CATHETERIZATI

Company / brand

ARROW INTERNATIONAL, LLC

Product

Description/REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1; EPIDURAL CATHETERIZATION KIT: 19 GA/AK-05501; EPIDURAL CATHETERIZATION KIT/AK-05502; EPIDURAL CATHETERIZATION KIT/AK-05502D; EPIDURAL CATHETERIZATION KIT/AK-05503; EPIDURAL CATHETERIZATION KIT/AK-05503-L; SPINAL ANES/EPIDURAL CATH KIT/AK-05560; SPINAL ANES/EPIDURAL CATH KIT/ASK-02520-SBMC1; EPIDURAL CATHETERIZATION KIT/ASK-05400-BW1; EPIDURAL CATHETERIZATION KIT/ASK-05400-GH; SPINAL ANES/EPIDURAL CATH KIT/ASK-05401-LMC; EPIDURAL CATHETERIZATION KIT/ASK-05401-NM; SPINAL ANES/EPIDURAL CATH KIT/ASK-05500-BID1; EPIDURAL CATHETERIZATION KIT: 19 GA/ASK-05500-JHH1; EPIDURAL CATHETERIZATION KIT: 19 GA/ASK-05500-MCV1; EPIDURAL CATHETER KIT: 19GA X 90CM ASK-05500-MVH; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05500-UMC; 19 GA X 35.5 IN EPIDURAL CATHETER KIT/ASK-05502-MLH; SPINAL ANES/EPIDURAL CATH KIT/ASK-05560-JMH1; SPINAL ANES/EPIDURAL CATH KIT/ASK-05560-MKD2; SPINAL ANES/EPIDURAL CATH KIT/ASK-05560-OM1; EPIDURAL CATHETERIZATION KIT/ASK-17019-SM; EPIDURAL CATHETERIZATION KIT/BP-05501; EPIDURAL CATHETERIZATION KIT/CK-05401; EPIDURAL CATHETERIZATION KIT/HS-05501; EPIDURAL CATHETERIZATION KIT/MM-05501; EPIDURAL CATHETERIZATION KIT: 19 GA/MP-17019-TK; EPIDURAL CATHETERIZATION KIT: 19 GA/MP-17019-TKD; EPIDURAL CATHETERIZATION KIT: 19 GA/MP-17019-TKL; EPIDURAL CATHETERIZATION KIT/MSO-05401-JMH; EPIDURAL CATHETERIZATION KIT/NM-05401; EPIDURAL CATHETERIZATION KIT/SJ-05501; EPIDURAL CATHETERIZATION KIT/SM-05401; EPIDURAL CATHETER KIT: 19 GA X 90 CM/TM-05401; EPIDURAL CATHETERIZATION KIT/TM-05502; SPINAL ANES/EPIDURAL CATH KIT/UI-05502; SPINAL ANES/EPIDURAL CATH KIT: 19 GA/ASK-05400-SHM; EPIDURAL CATH KIT: 19 GA/ASK-05400-UOM; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05500-MR; EPIDURAL CATHETERIZATION KIT: 19 GA/ASK-05500-TM; EPIDURAL CATHETERIZATION KIT/ASK-05501-BHL1; EPIDURAL CATHETERIZATION KIT/ASK-05501-GH; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05501-SM; EPIDURAL CATHETERIZATION KIT/ASK-05502-BSM; EPIDURAL CATHETERIZATION KIT/ASK-05502-MGH1; EPIDURAL CATHETERIZATION KIT/ASK-05503-BWB1; EPIDURAL CATHETERIZATION KIT/ASK-05503-HMH; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05503-SPH; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05503-UPM1; SPINAL ANES/EPIDURAL CATH KIT/ASK-05560-UCI2; EPIDURAL CATHETERIZATION KIT: 19 GA/ASK-17019-UMP; EPIDURAL CATHETERIZATION KIT/MH-05503-1; EPIDURAL CATHETERIZATION KIT/ASK-05401-VB2; Epidural Catheterization Kit: 19GA/ASK-05500-SC1; Epidural Catheterization Kit: 19GA/ASK-05500-SC3; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05501-AFH1; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05501-BMC; EPIDURAL CATHETERIZATION KIT/ASK-05502-NY; EPIDURAL CATHETERIZATION KIT/ASK-17019-RMH

Reason / hazard

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.

Classification

Class I

Status

Ongoing

Distribution / sold at

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.

Recall initiated

2026-04-21

Code info

REF(Material)/UDI-DI/Lot(Batch): ASK-05502-VM1/10801902210217, 10801902209938/33F25C0168, 33F25C0880, 33F25E0202, 33F25G0134, 33F25H0126, 33F26C0297, 33F24C0216; AK-05501/)10801902210217, 10801902209501, 10801902209518/33F24E0057, 33F24E0058, 33F24J0496, 33F24K0094, 33F24L0564, 33F25A0460, 33F25A0617, 33F25C0728,33F25E0043, 33F25E0913, 33F25G0081, 33F25H0015, 33F25J0465, 33F25J0822, 33F25K0254, 33F25L0376, 33F26C0300, 33F24B0119; AK-05502/10801902209518, 10801902210217, 10801902209525/33F24C0015, 33F24G0581, 33F24G0582, 33F24G0583, 33F24J0497, 33F24J0678, 33F24J0679, 33F24J0680, 33F24J0681, 33F24K0095, 33F24K0310, 33F24L0580, 33F24L0624, 33F24L0628, 33F24L0630, 33F24L0757, 33F24L0785, 33F25A0461, 33F25A0618, 33F25A0619, 33F25A0620, 33F25C0103, 33F25C0724, 33F25C0725, 33F25C0741, 33F25C0791, 33F25E0044, 33F25E0291, 33F25E0292, 33F25E0293, 33F25E0914, 33F25E1067, 33F25G0082, 33F25G0159, 33F25H0016, 33F25H0197, 33F25H0198, 33F25H0199, 33F25J0466, 33F25J0643, 33F25J0790, 33F25J0805, 33F25J0806, 33F25J0807, 33F25J0808, 33F25K0024, 33F25K0252, 33F25K0358, 33F25K0359, 33F25L0099, 33F25L0266, 33F25L0267, 33F25M0970, 33F25M0978, 33F26A1100, 33F24C0096; AK-05502D/10801902210217, 10801902209532/33F24G0331, 33F24J0498, 33F24K0096, 33F24L0713, 33F25A0462, 33F25C0745, 33F25E0045, 33F25H0017, 33F25J0467, 33F25L0366, 33F24C0017; AK-05503/10801902210217, 10801902209549/33F24J0277, 33F24J0499, 33F24K0097, 33F24L0674, 33F25A0463, 33F25C0949, 33F25E0046, 33F25E0915, 33F25H0018, 33F25J0823, 33F25L0406, 33F25M0912, 33F24C0018; AK-05503-L/10801902209549, 10801902210217, 10801902209549/33F24C0019, 33F24E0066, 33F24J0682, 33F24K0098, 33F24L0613, 33F24L0758, 33F25A0464, 33F25C0104, 33F25C0731, 33F25C0793, 33F25E0047, 33F25E0916, 33F25G0083, 33F25H0019, 33F25H0200, 33F25J0791, 33F25J0809, 33F25K0026, 33F25K0253, 33F25L0057, 33F25L0352, 33F25M0861, 33F26A0989, 33F24J0278; AK-05560/10801902210217, 10801902209556, 30801902121722/33F24J0501, 33F24K0099, 33F24L0552, 33F25A0145, 33F25A0465, 33F25C0743, 33F25E0048, 33F25E0917, 33F25G0084, 33F25H0020, 33F25J0737, 33F25J0824, 33F25M0895, 33F26B0538, 33F26C0592, 33F24A0812; ASK-02520-SBMC1/10801902209570, 10801902210217, 10801902193275/33F24D0103, 33F24F0275, 33F24G0396, 33F25A0137; ASK-05400-BW1/10801902209617, 10801902209631/33F24D0153, 33F24E0474, 33F24G0461, 33F24J0307, 33F24L0556, 33F25B0246, 33F25C0729, 33F25E0178, 33F25G0121, 33F25J0899, 33F25L0042, 33F25L0450, 33F24C0196; ASK-05400-GH/10801902209631, 10801902210217, 10801902202199/33F24D0154, 33F24E0480, 33F24G0292, 33F24J0310, 33F24J0600, 33F24L0597, 33F25A0153, 33F25C0161, 33F25C0754, 33F25E0181, 33F25G0123, 33F25J0532, 33F25L0391, 33F25M0897, 33F24D0155; ASK-05401-LMC/10801902210217, 10801902209662/33F24J0603, 33F25F0240, 33F25G0754, 33F25J0534, 33F24D0031; ASK-05401-NM/10801902210217/33F24E0104, 33F24G0295, 33F24J0311, 33F24J0604, 33F24K0223, 33F24L0559, 33F25A0548, 33F25C0840, 33F25E0184, 33F25G0125, 33F25H0113, 33F25J0535, 33F25L0024, 33F25L0361, 33F24E0027; ASK-05500-BID1/10801902210217/33F24E0490, 33F24G0297, 33F24H0488, 33F24J0607, 33F24L0594, 33F25A0551, 33F25C0823, 33F25E0187, 33F25G0127, 33F25J0536, 33F25L0438, 33F24K0228; ASK-05500-JHH1/10801902210217, 10801902209716, 10801902209723/33F24L0572, 33F25B0379, 33F25D0215, 33F25E0190, 33F25G0129, 33F25H0744, 33F25J0538, 33F25K0407, 33F25M0955, 33S24L0572, 33F24C0203; ASK-05500-MCV1/10801902210217/33F24E0494, 33F24E0495, 33F24G0470, 33F24J0611, 33F24K0229, 33F24L0707, 33F25A0554, 33F25C0784, 33F25E0191, 33F25E1005, 33F25G0761, 33F25H0115, 33F24E0496; ASK-05500-MVH/10801902209730, 10801902210217/33F24D0380, 33F24E0498, 33F24G0472, 33F24L0681; ASK-05500-UMC/10801902209754, 10801902210217/33F24D0382, 33F24J0316, 33F24K0233, 33F24L0085, 33F24L0772, 33F25C0166, 33F25C0737, 33F25E0196, 33F25E0317, 33F25E1008, 33F25H0120, 33F25J0540, 33F25L0397, 33F25M0904, 33F24E0502; ASK-05502-MLH/10801902210217/33F24J0618, 33F24K0239, 33F24L0555, 33F25A0562, 33F25C0996, 33F25E0201, 33F25H0125, 33F25J0544, 33F25L0440, 33F26B0977, 33F24L0583; ASK-05560-JMH1/10801902210217, 10801902209983/33F24G0483, 33F24L0773, 33F25A0566, 33F25C0894, 33F25E1014, 33F25H0130, 33F25J0548, 33F24E0519; ASK-05560-MKD2/10801902193275, 10801902210217/33F24K0246, 33F25G0468, 33F24J0476; ASK-05560-OM1/10801902210217, 10801902210002/33F24K0550, 33F25A0155, 33F25C0171, 33F25F0383, 33F25G0560, 33F25H0131, 33F25H0746, 33F25J0784, 33F25L0006, 33F25M0903, 33F24D0391; ASK-17019-SM/10801902210217, 10801902211221/33F25G0137, 33F25H0136, 33F25J0553, 33F25L0465, 33F24B0348; BP-05501/10801902210217, 10801902193275/33F24E0156, 33F24J0642, 33F24K0270, 33F25B0689, 33F25C0868, 33F25E1034, 33F25G0145, 33F25H0158, 33F25J0568, 33F25L0369, 33F26B0518, 33F25C0444; CK-05401/10801902202144, 10801902210217, 10801902193275/33F24C0256, 33F25A0591, 33F25C0972, 33F25E0256, 33F25E1040, 33F25H0756, 33F25J0935, 33F25L0244, 33F26B0620, 33F25D0674; HS-05501/10801902210217, 10801902202090/33F24E0580, 33F24J0329, 33F24B0389; MM-05501/10801902210217/33F24J0655, 33F24K0287, 33F24L0788, 33F25J0628, 33F25L0445, 33F24C0263; MP-17019-TK/10801902210217/33F24D0409, 33F24J0390, 33F24K0288, 33F24L0546, 33F25A0595, 33F25C0727, 33F25E0262, 33F25E1045, 33F25H0170, 33F25J0629, 33F25L0441, 33F25M0939, 33F24D0410; MP-17019-TKD/10801902210217, 10801902210224/33F24J0657, 33F24L0698, 33F25C0760, 33F25E0263, 33F25H0171, 33F25J0938, 33F24B0152; MP-17019-TKL/10801902210224, 10801902210217/33F24D0038, 33F24K0289, 33F24L0614, 33F25C0190, 33F25C0839, 33F25E0264, 33F25G0149, 33F25J0630, 33F25K0380, 33F24K0290; MSO-05401-JMH/10801902210217/33F25C0193, 33F25H0172, 33F25J0631, 33F25L0375, 33F25M0880, 33F24D0413; NM-05401/10801902210217, 10801902210262, 10801902140644/33F25J0944, 33F25M0968, 33F26B0600, 33F24C0780; SJ-05501/10801902210330, 10801902210217, 10801902202496/33F24C0049, 33F24C0050, 33F24J0382, 33F24J0383, 33F24J0384, 33F24J0385, 33F24J0386, 33F24K0552, 33F24K0553, 33F24K0554, 33F24K0555, 33F24K0556, 33F24K0557, 33F24L0625, 33F24L0721, 33F24L0760, 33F24L0786, 33F25A0605, 33F25A0623, 33F25A0624, 33F25C0202, 33F25C0789, 33F25C0790, 33F25C0945, 33F25C0997, 33F25E0278, 33F25E0295, 33F25E0296, 33F25E1057, 33F25E1068, 33F25G0154, 33F25G0160, 33F25H0183, 33F25H0202, 33F25H0203, 33F25J0639, 33F25J0644, 33F25J0798, 33F25J0811, 33F25J0812, 33F25J0813, 33F26B0601, 33F26C0299, 33F26C0307, 33F24A1336; SM-05401/10801902210217, 10801902210354, 10801902193275/33F24G0561, 33F24K0302, 33F24L0607, 33F25C0204, 33F25C0805, 33F25E0279, 33F25E1058, 33F25H0184, 33F25J0948, 33F26A1030, 33F24G0270; TM-05401/10801902210217, 30801902202155, 10801902210361/33F24D0418, 33F24G0563, 33F24J0669, 33F24L0089, 33F24L0741, 33F25C0207, 33F25C0918, 33F25E0282, 33F25E1059, 33F25J0950, 33F25L0447, 33F26C0308, 33F24B0410; TM-05502/10801902210378/33F24B0411; UI-05502/10801902210217/33F24G0565, 33F24J0670, 33F24L0562, 33F25A0607, 33F25C0881, 33F25E0283, 33F25E1060, 33F25G0752, 33F25H0186, 33F25J0951, 33F24A0359; ASK-05400-SHM/10801902210217/33F24E0482, 33F24G0465, 33F24J0601, 33F24K0221, 33F24L0800, 33F25C0162, 33F25C0888, 33F25E0182, 33F25H0741, 33F25L0457, 33F24E0483; ASK-05400-UOM/10801902210217/33F25G0124, 33F25H0742, 33F25K0263, 33F24G0294; ASK-05500-MR/10801902210217, 10801902209730/33F24E0497, 33F24G0471, 33F24K0230, 33F25A0555, 33F25C0796, 33F25E0192, 33F25H0116, 33F25K0408, 33F25M0854, 33F24C0204; ASK-05500-TM/10801902210217, 10801902209747, 10801902209754/33F25C0165, 33F25E1007, 33F25M0871, 33F26C0256, 33F24C0206; ASK-05501-BHL1/10801902210217/33F24L0566, 33F25A0558, 33F25C0810, 33F25E0197, 33F25E1009, 33F25H0121, 33F25J0541, 33F25L0439, 33F24E0503; ASK-05501-GH/10801902210217, 10801902210392/33F24K0235, 33F25A0559, 33F25E0198, 33F25H0122, 33F25J0542, 33F24D0384; ASK-05501-SM/10801902210217, 10801902210392, 10801902214857/33F24E0505, 33F24K0236, 33F25A0560, 33F25C0808, 33F25E0199, 33F25E1010, 33F25H0123, 33F25J0907, 33F26C0304, 33F24C0210; ASK-05502-BSM/10801902209853, 10801902210217/33F24D0385, 33F24E0508, 33F24G0301, 33F24K0237, 33F25A0154, 33F25B0687, 33F25H0124, 33F25J0543, 33F25K0409, 33F25L0466, 33F26B0592, 33F24E0509; ASK-05502-MGH1/10801902210217, 10801902209860/33F24J0617, 33F24L0569, 33F25B0247, 33F25C0938, 33F25E0304, 33F25G0133, 33F25J0909, 33F25L0098, 33F26B0545, 33F24J0318; ASK-05503-BWB1/10801902210217, 10801902209938, 10801902209952/33F24E0514, 33F24G0481, 33F24J0619, 33F24K0241, 33F24L0690, 33F25C0169, 33F25C0756, 33F25E1011, 33F25J0545, 33F25L0453, 33F26B0584, 33F24C0217; ASK-05503-HMH/10801902210217, 10801902209952, 10801902209969/33F24L0643, 33F25A0563, 33F25C0170, 33F25C0765, 33F25E1012, 33F25G0135, 33F25H0127, 33F25J0546, 33F25L0451, 33F26A1079, 33F24C0218; ASK-05503-SPH/10801902210217, 10801902209969, 10801902211405/33F24E0516, 33F24J0620, 33F24K0243, 33F24L0598, 33F25A0564, 33F25E0204, 33F25L0458, 33F25M0951, 33F24C0219; ASK-05503-UPM1/10801902211405, 10801902210217, 10801902209976/33F24D0389, 33F24E0160, 33F24J0621, 33F24K0244, 33F24L0549, 33F25A0565, 33F25C0992, 33F25E0205, 33F25E1013, 33F25H0129, 33F25J0547, 33F25L0454, 33F24D0390; ASK-05560-UCI2/10801902210217, 10801902193275/33F24G0485, 33F24J0623, 33F24L0593, 33F25A0567, 33F25C0893, 33F25E0206, 33F25E1015, 33F25H0132, 33F25J0911, 33F25L0061; ASK-17019-UMP/10801902210217, 10801902211221, 10801902210057/33F24J0628, 33F24K0250, 33F25B0694, 33F25E0216, 33F25H0137, 33F25J0916, 33F26B1000, 33F24B0350; MH-05503-1/10801902210217/33F25H0169, 33F24G0542 ASK-05401-VB2/10801902214840/33F24C0199, 33F24D0374, 33F24E0486, 33F24G0296, 33F24J0312, 33F24J0605, 33F24K0224, 33F24L0733, 33F25A0549; ASK-05500-SC1 /10801902202250/33F24B0319, 33F24C0205, 33F24D0381, 33F24E0499, 33F24G0299, 33F24J0315, 33F24J0613, 33F24K0232, 33F24L0567, 33F25A0557, 33F25C0884, 33F25E0194; ASK-05500-SC3/10801902223651/33F25G0751, 33F25H0118, 33F26B0644; ASK-05501-AFH1/10801902209761/33F24G0475; ASK-05501-BMC/10801902209785/33F24J0479; ASK-05502-NY/10801902209884/33F24E0512; ASK-17019-RMH/10801902214918/33F24B0346, 33F24E0531

Product quantity

1,525,831

Voluntary mandated

Voluntary: Firm initiated

City

Morrisville

State

NC

Country

United States

Event id

98793

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