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Recall Observatory FDA recall evidence

Device 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

Z-2391-2026

April 21, 2026

Class I

Product summary

Firm
ARROW INTERNATIONAL, LLC
Event
Event 98793
Status
Ongoing
Classification
Class I
Quantity
491,489
Official record key
device-enforcement:Z-2391-2026

Official wording

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.

Code information: 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;

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.