medical HIGH RISK Updated 2026-06-24

ARROW INTERNATIONAL, LLC recalls Description/REF: RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-SPC;

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Recalled Product

Description/REF: RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-SPC; RA CATH KIT: 20 GA X 5 IN/ASK-04020-MW; ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM5; CATH SL 20 GA X 5 CM HYDROPHILIC/ASK-00520-JH; CATH S-L 20 GA X 5 CM HYDROPHILIC/ASK-00520-UHC; ARTERIAL LINE KIT: 20 GA x 5IN/ASK-00820-CL; RA CATH KIT: 20 GA X 8 CM X 12 CM/ASK-00820-WC; ARTERIAL CATHETERIZATION KIT/ASK-01218-HM; SAC KIT: 20 GA X 12CM/ASK-01220-HMH; ARTERIAL CATH KIT: 20GA X 12CM/ASK-01220-NWM; ARTERIAL CATH KIT: 20 GA X 12 CM/ASK-01220-UH; ARTERIAL CATH: 18 GA X 6 1/2IN/ASK-01618-AU; RA CATH KIT: 18 GA X 6 IN/ASK-01618-CL; ARTERIAL CATH KIT: 18 GA X 6 1/2 IN/ASK-01618-JH; ARTERIAL CATHETERIZATION KIT/ASK-01618-PH; ARTERIAL CATH KIT: 18 GA X 6 1/2IN/ASK-01618-RU; ARTERIAL CATH KIT: 18 GA X 6IN (16 CM)/ASK-04018-HF; ARTERIAL CATH KIT: 18 GA X 6 IN (16 CM)/ASK-04018-NS; ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018-ST; RA CATH KIT: 20 GA X 1 1/2 IN (3.81 CM)/ASK-04120-BGH; ART/VESS CATH KIT:20GAX4.45CM/20GAX12CM/ASK-04500-SM; ARTERIAL LINE KIT/ASK-04500-UCH; ARTERIAL LINE KIT/ASK-04510-EUH2; ARTERIAL LINE KIT: 20GA X 5IN (12CM)/ASK-04510-MS4; ARTERIAL LINE KIT/ASK-04510-UPM; ARTERIAL CATH KIT: 20GA X 5CM/SAC-00520-1A; ARTERIAL CATH KIT: 20GA X 5CM/SAC-00520-X1A; ARTERIAL CATH KIT: 22GA X 5CM/SAC-00522-1A ARTERIAL CATH KIT: 22 GA X 5CM/SAC-00522-X1A; ARTERIAL CATH KIT: 20GA X 8CM/SAC-00820-1A; ARTERIAL CATH KIT: 20GA X 8CM/SAC-00820-X1A; SAC KIT: 18 GA X 12CM/SAC-01218-1A; SAC KIT: 18 GA X 12CM/SAC-01218-X1A; SAC KIT: 20 GA X 12CM/SAC-01220-1A; SAC KIT: 20 GA X 12CM/SAC-01220-X1A; SAC KIT: 18 GA X 16CM/SAC-01618-1A; SAC KIT: 18 GA X 16CM/SAC-01618-X1A; ACCESS TRAY/UM-04018; RA CATH KIT: 20 GA X 4.45 CM/ASK-04020-ABM; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-BGH; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-LOL; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-MHS; RA CATH KIT: 20 GA X 1 3/4IN (4.45 CM)/ASK-04020-MIB3; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-PMC1; RA CATH SET: 20 GA X 1 3/4 IN/ASK-04020-URMC; RA CATH KIT: 20 GA X 1 1/2 IN (3.81 CM)/ASK-04220-FMH1; RA CATH KIT: 20 GA X 4.45 CM/NA-04020-1A; RA CATH KIT: 20 GA X 4.45 CM W BIO/NA-04020-B; RA CATH KIT: 20 GA X 4.45 CM W CHG/NA-04020-C; VESSEL CATH KIT: 20 GA X 5IN (12 CM)/ASK-04550-NYP; CVC KIT: 16 GA X 8 IN (20 CM)/ASK-04300-PHP1; CVC KIT: 16 GA X 8 IN (20 CM)/ASK-04301-TJ; ARTERIAL ACCESS KIT/ASK-04001-VAMC1; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-WBH

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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): AK-04020-SPC/10801902121551, 10801902193275/33F23M0171, 33F24C0729, 33F24E0699, 33F24G0596, 33F24H0057, 33F24J0350, 33F24J0458, 33F24K0615, 33F24M0126, 33F25A0338, 33F25B0039, 33F25B0131, 33F25D0192, 33F25D0281, 33F25E1109, 33F25F0496, 33F25J0764, 33F26B0054; ASK-04020-MW/10801902142983, 10801902193275/33F23M0188, 33F24B0447, 33F24C0744, 33F24E0725, 33F24G0231, 33F24G0669, 33F24H0344, 33F24L0005, 33F24L0024, 33F25A0062, 33F25B0064, 33F25D0290, 33F25D0729, 33F25E0428, 33F25H0328, 33F26B0089, 33F26B0263; ASK-04510-MM5/10801902193275/33F24K0360, 33F25A0237, 33F25B0546; ASK-00520-JH/10801902138788, 10801902193275/33F24D0201, 33F24F0686, 33F24J0128, 33F24K0373, 33F25A0204, 33F25B0541, 33F25D0324, 33F25D0645, 33F25H0429, 33F25H0507, 33F25J0195, 33F26A1380, 33F26B0159, 33F26C0192; ASK-00520-UHC/10801902139839, 10801902193275/33F23L0771, 33F24A0775, 33F24B0219, 33F24C0125, 33F24D0093, 33F24E0383, 33F24G0386, 33F24J0284, 33F24K0149, 33F24L0712, 33F25A0495, 33F25C0125, 33F25C0826, 33F25E0099, 33F25H0047, 33F25J0851, 33F25L0392, 33F26B0540; ASK-00820-CL/10801902193275, 10801902193916/33F24G0275, 33F24J0285, 33F24K0152, 33F24L0590, 33F25A0497, 33F25C0797, 33F25E0102, 33F25H0050, 33F25J0853, 33F25L0385, 33F26B0536; ASK-00820-WC/10801902193275/33F24G0150, 33F24G0227, 33F24G0691, 33F24H0253, 33F24K0624, 33F25B0091, 33F25B0334, 33F25J0574, 33F26B0113; ASK-01218-HM/10801902193275/33F24G0276, 33F24K0551, 33F24L0215, 33F25A0296, 33F25B0543, 33F25E0450, 33F25F0364, 33F25G0163, 33F25G0208, 33F25H0499, 33F25J0100, 33F25J0139; ASK-01220-HMH/10801902193275/33F25B0245, 33F25B0544, 33F25C0698, 33F25D0388; ASK-01220-NWM/10801902193275/33F24H0181, 33F24J0154, 33F24K0497, 33F25F0157, 33F25H0658; ASK-01220-UH/10801902193275/33F24G0391, 33F24J0286, 33F24J0541, 33F24K0154, 33F24L0663, 33F25C0126, 33F25E0104, 33F25E0955, 33F25H0052, 33F25J0494, 33F25J0855, 33F25L0459, 33F25M0952; ASK-01618-AU/10801902205909, 10801902193275/33F24F0213, 33F24K0673, 33F25C0653, 33F25E1171, 33F25L0062, 33F26A0233; ASK-01618-CL/10801902195934, 10801902193275/33F24E0648, 33F24K0355, 33F25A0224,33F25B0493, 33F25D0327, 33F25E0588, 33F25F0158, 33F25J0140, 33F25M0112, 33F26C0366; ASK-01618-JH/10801902138801, 10801902193275/33F24D0584, 33F24K0490, 33F24L0844, 33F25B0494, 33F25D0530, 33F25H0834, 33F25K0264, 33F25K0357, 33S25D0530; ASK-01618-PH/10801902193275/33F24K0749, 33F24L0837, 33F25C0251, 33F25E0019, 33F25G0220; ASK-01618-RU/10801902202304, 10801902193275/33F24B0869, 33F24D1027, 33F25A0102, 33F25C0713, 33F25J0792, 33F25M0618; ASK-04018-HF/10801902193275/33F24H0156, 33F24L0397, 33F25D0391, 33F25G0401, 33F25K0069, 33F25M0142; ASK-04018-NS/10801902193275/33F25E1176, 33F25G0103; ASK-04018-ST/10801902117639, 10801902193275/33F24A0112, 33F24A0826, 33F24B0237, 33F24C0140, 33F24E0402, 33F24E0403, 33F24G0281, 33F24K0163, 33F25A0504, 33F25C0780, 33F25E0115, 33F25G0104, 33F25J0498, 33F25M0917, 33F26B1011; ASK-04120-BGH/10801902117936, 10801902193275/33F24D0518, 33F24G0262, 33F24J0474, 33F25A0150, 33F25C0740, 33F25E1207, 33F25H0096, 33F25K0331; ASK-04500-SM/30801902118012, 10801902193275/33F24A0117, 33F24A1163, 33F24D0059, 33F24D0968, 33F24E0782, 33F24G0263, 33F24J0302, 33F25C0500, 33F25E0162, 33F25H0738, 33F25L0209, 33F25M0617, 33F26B0020, 33F26B0746; ASK-04500-UCH/10801902139464, 10801902193275/33F24E0454, 33F24G0446, 33F24J0588, 33F24K0207, 33F24L0715, 33F25C0155, 33F25C0924, 33F25E0163, 33F25H0739, 33F25L0332, 33F26B0655; ASK-04510-EUH2/10801902193275, 10801902213386/33F24J0303, 33F24L0728, 33F25C0156, 33F25C0803, 33F25E0164, 33F25H0103, 33F25J0522, 33F25L0343, 33F25M0850, 33F26B0660; ASK-04510-MS4/10801902193275, 10801902139709/33F24K0212, 33F24L0764, 33F25C0860, 33F25E0169, 33F25E0994, 33F25J0526, 33F25L0423, 33F26B0654; ASK-04510-UPM/10801902118087, 10801902193275/33F24B0144, 33F24E0101, 33F24E0102, 33F24G0456, 33F24J0595, 33F24K0216, 33F24L0675, 33F25A0544, 33F25C0947, 33F25E0174, 33F25H0107, 33F25J0529, 33F25J0738, 33F25L0022, 33F26B0647, 33F26B0665, 33F26C0617; SAC-00520-1A/10801902140644, 10801902193275/33F24C0780, 33F24E0772, 33F24G0025, 33F24G0675, 33F24H0061, 33F24J0190, 33F24J0207, 33F24J0415, 33F24M0010, 33F25A0097, 33F25B0052, 33F25B0126, 33F25B0410, 33F25C0540, 33F25D0185, 33F25E0408, 33F25E0472, 33F25G0530, 33F25H0832, 33F25J0045, 33F25J1013, 33F25M0704, 33F26B0259; SAC-00520-X1A/10801902193275, 10801902140583/33F24J0208, 33F25A0098, 33F25B0023, 33F25B0127, 33F25B0287, 33F25D0086, 33F25E1180, 33F25F0288, 33F25F0425, 33F25H0347, 33F25H0866, 33F25L0177, 33F26B0058, 33F26B0279; SAC-00522-1A/10801902140606, 10801902193275/33F23L0976, 33F24B0461, 33F24C0783, 33F24E0775, 33F24G0243, 33F24J0242, 33F24J0416, 33F24M0122, 33F25A0389, 33F25B0076, 33F25E0382, 33F25H0348, 33F26B0257; SAC-00522-X1A/10801902193275/33F24L0536, 33F26B0059; SAC-00820-1A/10801902140637, 10801902193275/33F24B0463, 33F24C0785, 33F24E0777, 33F24F0081, 33F24G0136, 33F24H0059, 33F24H0352, 33F24H0388, 33F24L0057, 33F24M0011, 33F24M0123, 33F25A0134, 33F25B0109, 33F25B0282, 33F25B0646, 33F25C0543, 33F25C0568, 33F25D0094, 33F25D0186, 33F25D0302, 33F25E0364, 33F25F0045, 33F25J0581, 33F25J0980, 33F25K0298, 33F25K0338; SAC-00820-X1A/10801902193275, 10801902140620/33F25C0491, 33F25C0544, 33F25D0073, 33F25E0409, 33F25F0055, 33F25H0801, 33F25J0660, 33F25K0337, 33F25L0193, 33F25M0697, 33F26B0068, 33F26B0702; SAC-01218-1A/10801902199734, 10801902193275/33F24A1699, 33F24D0559, 33F24E0668, 33F24F1031, 33F25A0203, 33F25C0455, 33F25D0580, 33F25J0189, 33F26C0035; SAC-01218-X1A/10801902193275, 10801902199741/33F24J0138, 33F24L0960, 33F25A0294, 33F25B0537, 33F25C0479, 33F25E0768, 33F25H0618, 33F25J0451, 33F26A1374, 33F26B0775; SAC-01220-1A/10801902199758, 10801902193275/33F24C0971, 33F24D0361, 33F24F0986, 33F24L0509, 33F25A0221, 33F25B0481, 33F25C0374, 33F25D0635, 33F25E0711, 33F25G0297, 33F25J0133, 33F26A1362, 33F26B0458, 33F26C0680; SAC-01220-X1A/10801902193275, 10801902140989/33F24J0163, 33F24L0148, 33F25A0194, 33F25B0470, 33F25B0680, 33F25D0636, 33F25E0841, 33F25G0411, 33F25J0259, 33F26A1449, 33F26B0202, 33F26C0168; SAC-01618-1A/10801902199765, 10801902193275/33F24A0983, 33F24A1565, 33F24C0373, 33F24C1010, 33F24D0323, 33F24D0875, 33F24F0992, 33F24K0364, 33F24L0394, 33F24L1126, 33F25A0295, 33F25B0510, 33F25C0250, 33F25D0258, 33F25D0385, 33F25D0581, 33F25E0712, 33F25E0903, 33F25F0231, 33F25G0402, 33F25J0123, 33F25J0340, 33F26A1356, 33F26A1509, 33F26B0941, 33F26D0311; SAC-01618-X1A/10801902193275, 10801902145489/33F24J0144, 33F24L0395, 33F25A0222, 33F25B0511, 33F25D0259, 33F25D0321, 33F25D0458, 33F25E0770, 33F25F0232, 33F25G0264, 33F25G0383, 33F25J0134, 33F25J0452, 33F26A1435, 33F26B0842, 33F26B0939, 33F26B0940; UM-04018/10801902192063, 10801902193275/33F24A0359, 33F24A0360, 33F24A0361, 33F24A1061, 33F24A1062, 33F24B0162, 33F24B0163, 33F24B0164, 33F24C0053, 33F24D0042, 33F24D0043, 33F24H0463, 33F24H0464, 33F24J0466, 33F24K0306, 33F24K0311, 33F24K0543, 33F24L0723, 33F24L0761, 33F25A0608, 33F25C0209, 33F25E0284, 33F25E0297, 33F25E0742, 33F25E1061, 33F25E1069; ASK-04020-ABM/10801902193275, 10801902218947/33F24J0341, 33F24J0551, 33F24L0700, 33F25C0923, 33F25E0117, 33F25J0500, 33F25L0468, 33F26B0995; ASK-04020-BGH/10801902117660, 10801902193275/33F24A0814, 33F24C0142, 33F24D0109, 33F24E0406, 33F24G0404, 33F24J0554, 33F24L0634, 33F25A0507, 33F25C0809, 33F25E0120, 33F25H0064, 33F25J0867, 33F25L0386, 33F25M0890; ASK-04020-LOL/10801902193275, 10801902144765/33F24G0417, 33F24J0566, 33F24K0180, 33F24L0780, 33F25C0993, 33F25H0077, 33F25H0733, 33F25J0670, 33F25L0425, 33F26C0318, 33S24B0254, 33S24C0155; ASK-04020-MHS/20801902117711, 10801902193275/33F24A0380, 33F24A1033, 33F24B0255, 33F24C0157, 33F24D0121, 33F24E0420, 33F24H0476, 33F24J0568, 33F24K0181, 33F25C0990, 33F25E0137, 33F25G0111, 33F25H0078, 33F25J0505, 33F25L0377, 33F26B0526, 33S24A1033, 33S24B0255, 33S24C0157, 33S24D0121, 33X24K0003; ASK-04020-MIB3/10801902193275/33F24L0687, 33F25C0859, 33F25E0981, 33F25J0878, 33F26A0967; ASK-04020-PMC1/10801902193275/33F25C0489; ASK-04020-URMC/10801902117868, 10801902193275/33F24A0142, 33F24A0870, 33F24B0274, 33F24C0173, 33F24D0136, 33F24E0442, 33F24G0436, 33F24L0644, 33F25A0530, 33F25E0151, 33F25H0091, 33F25J0888; ASK-04220-FMH1/10801902193275/33F24K0203, 33F25A0535, 33F25E0158, 33F25J0890; NA-04020-1A/10801902119916, 10801902193275/33F24A1057, 33F24B0153, 33F24C0045, 33F24D0039, 33F24G0549, 33F24J0333, 33F24K0293, 33F24L0678, 33F25A0597, 33F25C0900, 33F25E0267, 33F25E1047, 33F25G0150, 33F25H0174, 33F25H0666, 33F25J0664, 33F25K0403, 33F25L0023, 33F25L0436, 33F25M0936, 33F26B0577; NA-04020-B/10801902193275, 10801902221312/33F24L0072, 33F25A0598, 33F25C0763, 33F25E0268, 33F25E1048, 33F25H0175, 33F25H0667, 33F25J0632, 33F26B0530; NA-04020-C/10801902193275, 10801902221329/33F24L0073, 33F25A0599, 33F25C0926, 33F25E0269, 33F25E1049, 33F25G0151, 33F25H0176, 33F25H0668, 33F26B0529; ASK-04550-NYP/10801902130836, 10801902193275/33F24F0685, 33F24H0144, 33F24K0424, 33F25A0166, 33F25B0170, 33F25B0495, 33F25D0337, 33F25G0355, 33F25H0431, 33F25H0639, 33F26A1367, 33F26A1542, 33F26C0585; ASK-04300-PHP1/10801902143805, 10801902193275/33F24F0619, 33F24H0147, 33F24K0072, 33F24M0047, 33F25C0649, 33F25K0314, 33F25L0029, 33F25M0066; ASK-04301-TJ/20801902114987, 10801902193275/33F24D0733, 33F24F0798, 33F25A0235, 33F25B0516; ASK-04001-VAMC1/10801902158854, 10801902193275/33F24E0400, 33F24G0400, 33F24K0161, 33F25A0502, 33F25E0114, 33F25J0863, 33F25L0387, 33F26B1016; ASK-04020-WBH/10801902117899/33F24C0174, 33F24D0138, 33F24E0445, 33F24G0438, 33F24J0582, 33F24L0793;

✅ 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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