FDAFDA recall Z-2391-2026 · Jun 24, 2026

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

Recall found

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

Reason for recall

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 to do

FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.

Recall details

FDA classification: Class I: FDA's most serious class, where use of or exposure to the product may cause serious health problems or death.
Status: Ongoing
Codes, lots and dates: 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;
Quantity: 491,489
Distribution: 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.
Recalling firm: ARROW INTERNATIONAL, LLC, Morrisville, NC
Voluntary or mandated: Voluntary: Firm initiated
Recall started: 2026-04-21

Source: openFDA enforcement record Z-2391-2026 · search recall number Z-2391-2026 in FDA's Enforcement Report.

Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.