Recall Ledger

Description/REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1 recall (ARROW INTERNATIONAL, LLC)

Medical deviceClass IOngoing

Summary: ARROW INTERNATIONAL, LLC is recalling 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/EPIDURA. 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 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.

What is being recalled

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

Why

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.

How serious is it

Class I is the most serious level: FDA considers there is a reasonable probability that using or being exposed to this product will cause serious health problems or death.

Where it was sold

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. (states named: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, Wyoming)

How to tell if yours is affected

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

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall numberZ-2371-2026
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass I
StatusOngoing
Recall startedApril 21, 2026
ReportedJune 24, 2026
CompanyARROW INTERNATIONAL, LLC
Company locationMorrisville, NC, United States
Initiated byVoluntary: Firm initiated
Quantity1,525,831

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Official FDA record