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Recall Observatory FDA recall evidence

Device product

Description/REF: RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-1A; RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-X1A; ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018-HCA; ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018-UPM; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-HC; ARTERIAL LINE KIT: 20 GA X 5IN (12 CM)/ASK-04020-HMC; RADIAL ARTERY CATHETER KIT: 20 GA X 30MM/ASK-04020-MMC; RA CATH KIT: 20 GA X 1-1/2IN (3.81 CM)/ASK-04020-SV; ARTERIAL CATH KIT: 20 GA X 5 IN (12 CM)/ASK-04100-AMC-S1; ARTERIAL CATHETER KIT: 20 GA X 12 CM/ASK-04100-NS; RADIAL ARTERY KIT/ASK-04500-AH; RAD ART:20GAX3.81CM / ART LINE:20GAX12CM/ASK-04500-HF-S; ARTERIAL LINE KIT: 1L 20 GA X 12 CM/ASK-04510-HA; ARTERIAL LINE KIT: 20 GA. X 5 IN (12 CM)/ASK-04510-HF; ARTERIAL LINE KIT: 20 GA X 5 IN (12 CM)/ASK-04510-IHC1; ARTERIAL LINE KIT: 20 GA X 5 IN (12 CM)/ASK-04510-MSK2; ARTERIAL CATH KIT: 20GA X 5IN/ASK-04510-NS; ARTERIAL CATHETER KIT: 20 GA X 12 CM/FS-04510-S; ARTERIAL LINE KIT/HF-04510-1; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-BSM; RA CATH KIT: 20 GA X 1 3/4 IN (4.45CM)/ASK-04020-HH1; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-JMH1; RA CATH KIT: 20 GA X 1-3/4 IN/ASK-04020-MAS; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-MCC; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MHT; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MI; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-MIHS; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MUSC; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-NCB; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-PMC; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-SPH; RA CATH SET: 20 GA X 1-3/4IN (4.45CM)/ASK-04020-UPM; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-UR1; RA CATH KIT: 20 GA X 4.45 CM/NA-04020-X1A; RA CATH KIT: 20 GA X 1-3/4IN/WBH-04020-1; CVC KIT: 20 GA X 12CM/ASK-04510-UCLA; ARTERIAL ACCESS TRAY WITH .025IN SWG/ASK-04001-BW1

Z-2397-2026

April 21, 2026

Class I

Product summary

Firm
ARROW INTERNATIONAL, LLC
Event
Event 98793
Status
Ongoing
Classification
Class I
Quantity
310,606
Official record key
device-enforcement:Z-2397-2026

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): NA-04220-1A/10801902193275/33F26B0027; NA-04220-X1A/10801902193275/33F24G0553, 33F25E0272, 33F25E1053, 33F25H0760, 33F25J0636; ASK-04018-HCA/10801902119268/33F24A0078; ASK-04018-UPM/50801902117644, 10801902193275/33F23B0953, 33F24A0389, 33F24B0140, 33F24D0028, 33F24H0480, 33F24J0550, 33F24K0164, 33F25A0505, 33F25C0742, 33F25C0792, 33F25E0961, 33F25E1070, 33F25E1071, 33F25E1072, 33F25G0105, 33F25H0062, 33F25J0866, 33F25L0353, 33F26B0507; ASK-04020-HC/10801902121384, 10801902193275/33F24A0828, 33F24B0246, 33F24C0148, 33F24D0113, 33F24G0409, 33F24J0559, 33F24K0172, 33F24L0693, 33F25C0136, 33F25C0933, 33F25E0128, 33F25H0070, 33F25L0356; ASK-04020-HMC/10801902117691, 10801902193275/33F24A0324, 33F24A0743, 33F24B0248, 33F24C0150, 33F24D0115, 33F24H0475, 33F24K0174, 33F24L0802, 33F25H0072, 33F25J0872, 33F25L0395, 33F26B0650, 33S24A0743, 33S24C0150, 33F26B0673; ASK-04020-MMC/10801902117769, 10801902193275/33F24C0160, 33F24D0123, 33F24E0423, 33F24G0420, 33F24H0487, 33F24J0571, 33F24K0183, 33F24L0692, 33F25A0523, 33F25C0974, 33F25E0139, 33F25H0081, 33F25J0880, 33F25L0346, 33F25M0853; ASK-04020-SV/10801902117837, 10801902117837/33F24A0868, 33F24B0269, 33F24E0436, 33F24E0437, 33F24L0746, 33F25H0087, 33F25J0885, 33F26B0512; ASK-04100-AMC-S1/10801902124927, 10801902193275/33F24D0139, 33F24E0446, 33F24G0439, 33F24K0199, 33F25A0532, 33F25E0153, 33F25G0116, 33F25H0093, 33F25J0516, 33F26B0656; ASK-04100-NS/10801902193275, 10801902117929/33F24G0440, 33F24L0579, 33F24M0266, 33F25A0533, 33F25C0151, 33F25C0788, 33F25E0155, 33F25H0095, 33F25J0518, 33F25K0256, 33F25L0448, 33F25M0945, 33F26B0649, 33F26B0667; ASK-04500-AH/10801902114041, 10801902193275/33F24A0153, 33F24A0803, 33F24B0282, 33F24C0181, 33F24E0452, 33F24G0444, 33F24J0586, 33F25A0538, 33F25H0101, 33F25J0893; ASK-04500-HF-S/10801902118001, 10801902193275/33F24A0141, 33F24A0753, 33F24A1157, 33F24B0283, 33F24C0182, 33F24D0143, 33F24E0453, 33F24G0445, 33F24J0587, 33F24K0206, 33F24L0766, 33F25C0154, 33F25C0966, 33F25E0161, 33F25H0102, 33F25J0894, 33F25L0492, 33R25C0966; ASK-04510-HA/10801902193275/33F24J0591, 33F24K0210, 33F25B0685, 33F25C0911, 33F25E0166, 33F25E0993, 33F25J0524, 33F25L0449; ASK-04510-HF/10801902193275, 10801902118025/33F24G0450, 33F24J0305, 33F24K0211, 33F24L0543, 33F24L0558, 33F25A0540, 33F25C0896, 33F25E0167, 33F25G0119, 33F25H0104, 33F25J0525, 33F25K0412, 33F25L0339, 33F26B0648, 33F26B0666, 33F26C0588; ASK-04510-IHC1/10801902193275/33F24J0306, 33F24L0699, 33F25C0157, 33F25C0782, 33F25E0168, 33F25H0105, 33F25L0475; ASK-04510-MSK2/10801902118049, 10801902193275/33F24A0872, 33F24B0290, 33F24D0150, 33F24E0461, 33F24G0453, 33F24J0594, 33F25A0541, 33F25C0852, 33F25E0170, 33F25H0740; ASK-04510-NS/10801902193275, 10801902224177/33F25K0324, 33F26B0653; FS-04510-S/10801902193275, 10801902119824/33F24L0738, 33F25C0188, 33F25C0755, 33F25L0426, 33F26B0657; HF-04510-1/10801902119855, 10801902193275/33F24D0036, 33F24G0537, 33F24J0652, 33F24L0576, 33F25A0593, 33F25C0897, 33F25E0260, 33F25E1044, 33F25H0166, 33F25J0936, 33F26B0652, 33F26B0675; ASK-04020-BSM/10801902193275/33F24J0365, 33F24M0075, 33F25A0079, 33F25B0312, 33F25D0116, 33F25D0297, 33F25E0367, 33F25F0400, 33F25G0653, 33F25J0983, 33F25L0155; ASK-04020-HH1/10801902193275, 10801902128536/33F24K0173, 33F24L0729, 33F25C0137, 33F25C0914, 33F25E0129, 33F25H0071, 33F25J0871, 33F25L0420, 33F26B0563; ASK-04020-JMH1/10801902114089, 10801902193275/33F24A0792, 33F24C0152, 33F24D0117, 33F24E0416, 33F24H0481, 33F24J0562, 33F24L0775, 33F25A0515, 33F25C0139, 33F25C0970, 33F25E0975, 33F25H0074, 33F25J0875, 33F25L0330, 33F26A0969; ASK-04020-MAS/10801902193275/33F25K0032; ASK-04020-MCC/10801902193275/33F24K0063, 33F24M0043; ASK-04020-MHT/10801902117721, 10801902193275/33F24A0094, 33F24B0019, 33F24D0052, 33F24D0966, 33F24J0475, 33F24L0083, 33F25C0739, 33F25E0980, 33F25F0529, 33F25J0506, 33F25K0329, 33F26A0403, 33F26C0056, 33F26C0260; ASK-04020-MI/10801902193275/33F24K0549, 33F25A0521, 33F25E1149, 33F25F0453, 33F25G0679, 33F25H0079, 33F25H0734, 33F25J0794, 33F25K0327, 33F25L0207, 33F25M0689, 33F26A0398; ASK-04020-MIHS/10801902193275/33F25A0442, 33F25B0233, 33F25C0379, 33F25D0035, 33F25H0494, 33F25K0426; ASK-04020-MUSC/10801902117776, 10801902193275/33F24A0751, 33F24A1138, 33F24B0259, 33F24C0162, 33F24D0125, 33F24E0425, 33F24G0421, 33F24K0184, 33F24L0640, 33F25C0141, 33F25C0830, 33F25E0140, 33F25H0083, 33F25J0881, 33F26B0575; ASK-04020-NCB/10801902117783, 10801902193275/33F24A0864, 33F24B0260, 33F24C0163, 33F24E0426, 33F24G0422, 33F24J0572, 33F24K0185, 33F24L0711, 33F25C0921, 33F25E0141, 33F25H0084, 33F25J0508, 33F25M0857; ASK-04020-PMC/30801902158896, 10801902193275/33F24F0095, 33F24L0242; ASK-04020-SPH/10801902193275/33F25C0143, 33F25C0977, 33F25E0985, 33F25H0735, 33F26A1075; ASK-04020-UPM/10801902117851, 10801902193275/33F24A0255, 33F24A0385, 33F24A1037, 33F24B0141, 33F24C0033, 33F24E0095, 33F24G0434, 33F24J0299, 33F24K0195, 33F24L0578, 33F25A0529, 33F25C0147, 33F25C0898, 33F25E0149, 33F25H0090, 33F25J0886, 33F25L0405, 33F26B0553; ASK-04020-UR1/10801902193275/33F24K0196, 33F24L0748, 33F25C0148, 33F25C0850, 33F25E0150, 33F25G0114, 33F25L0460, 33F25M0953; NA-04020-X1A/10801902193275, 30801902119927/33F24J0683, 33F24K0295, 33F24L0575, 33F24L0784, 33F25A0601, 33F25A0622, 33F25C0951, 33F25E0271, 33F25E1051, 33F25G0153, 33F25H0178, 33F25J0634, 33F25J0941, 33F25K0322, 33F25K0323, 33F25L0327, 33F25M0837, 33F26B0491; WBH-04020-1/10801902162943, 10801902193275/33F24B0465, 33F24C0787, 33F24E0780, 33F24G0659, 33F24J0435, 33F25A0124, 33F25B0054, 33F25B0110, 33F25B0227, 33F25C0404, 33F25C0522, 33F25E1163, 33F25G0630, 33F25H0349, 33F25J0080, 33F25L0162, 33F26B0060, 33F26C0408; ASK-04510-UCLA/10801902118070, 10801902193275/33F24C0189, 33F24E0465, 33F24G0455, 33F24K0215, 33F25A0543, 33F25C0861, 33F25E0173, 33F25H0106, 33F25J0897, 33F25L0347; ASK-04001-BW1/10801902117585/33F24D0105, 33F24G0277, 33F24H0240, 33F24J0546, 33F24K0158;

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.