medical HIGH RISK Updated 2026-06-24

ARROW INTERNATIONAL, LLC recalls Description/REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-0

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Recalled 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

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Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/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

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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