FDAFDA · Food and drugs·Recall number Z-2368-2026

Description/REF: RA CATH KIT: 20 GA X 1 3/4 IN/TJ-04020-1; RA CATH KIT: 20 GA X 1 1/2IN/NA-04220-S1A; ARTERIAL LINE KIT/AK-04510-S; ARTERIAL CATH KIT: 18 GA X 6IN (16 CM)/ASK-04018-HUMC; ARTERIAL LINE KIT: 18 GA X 6 IN (16 CM)/ASK-04018-OH1; RA CATH KIT: 20 GA X 1 3/4IN (4.45 CM)/ASK-04020-BID; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-MAR; ARTERIAL LINE KIT: 20 GA X 5 IN/ASK-04020-PM4; RA CATH KIT: 20 GA X 1 1/2IN (3.81 CM)/ASK-04120-HF3; RA CATH SET: 20 GA X 2 1/2 IN (6.35 CM)/ASK-04120-UR; ARTERIAL CATH KIT: 20 GA X 3 1/16 IN/ASK-04125-MGH; ARTERIAL CATH KIT: 20 GA X 5 IN/ASK-04500-HFH4; ARTERIAL LINE KIT: 20GA X 5IN/ASK-04510-BID2; ARTERIAL LINE KIT: 20GA X 5IN (12 CM)/ASK-04510-EHP1; ARTERIAL LINE KIT/ASK-04510-FEM1; ARTERIAL LINE KIT: 20 GA X 5 IN (12 CM)/ASK-04510-HFH; ARTERIAL CATH KIT: 20 GA X 5 IN/ASK-04510-HFH4; ARTERIAL LINE KIT/ASK-04510-SE; ARTERIAL LINE KIT: 20 GA X 5 IN (12CM)/ASK-04510-TGH2; RA CATH KIT: 20 GA X 12 CM/NA-04550-1A; RA CATH KIT: 20 GA X 12 CM/NA-04550-X1A; RA CATH KIT: 18 GA X 1-3/4IN/AK-04018; RA CATH KIT: 20 GA X 1-3/4IN/AK-04020; RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-C; RA CATH KIT: 20 GA X 1-1/2IN/AK-04120; RA CATH KIT: 22 GA X 1-3/8IN/AK-04122; RA CATH KIT: 20 GA X 1-1/2IN/AK-04220; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-AH; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-ATH; RA CATH KIT: 20 GA X 1 3/4IN (4.45CM)/ASK-04020-AU2; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-BHS; ARTERIAL CATHETERIZATION KIT/ASK-04020-BIDB2; RA CATH KIT: 20 GA X 4.45 CM/ASK-04020-CCD1; ARTERIAL CATHETERIZATION KIT/ASK-04020-CR; ART LINE KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-EUH2; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-FAM1; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-FMC; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-KSF2; RA CATH KIT: 20 GA X 1 3/4 IN (4.5 CM)/ASK-04020-LHC2; RA CATH KIT: 20 GA X 1 3/4 IN (4.5 CM)/ASK-04020-LHC3; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-LM; RA CATH KIT: 20 GA X 1 3/4IN/ASK-04020-MCH1; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MIH1; RA CATH KIT: 20 GA X 4.45 CM/ASK-04020-NWMX; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-PHP; RA CATH KIT: 20 GA X 1-3/4 IN (4.45CM)/ASK-04020-RIHM; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-RMC1; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-RU; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-SE; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-SHM; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-SRMC1; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-UCL1; RA CATH KIT: 20 GA X 4.45 CM/ASK-04020-UMI; RA CATH KIT: 20 GA X 1-3/4 IN (4.45CM)/ASK-04020-UN; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-UNC; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-UNC1; RA CATH SET: 20 GA X 1-1/2IN (3.81CM)/ASK-04220-PSU; RA CATH KIT: 20 GA X 1-1/2 IN (3.81 CM)/ASK-04220-UCL1; RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-S1A; CVC KIT: 20 GA X 5 IN (12CM)/ASK-04550-JMC1; ARTERIAL ACCESS TRAY/ASK-04001-BW2; ARTERIAL ACCESS TRAY WITH .025 IN SWG/ASK-04001-WUH1; ARTERIAL LINE KIT/ASK-04510-HUM

Published June 24, 2026 · Recall initiated: April 21, 2026

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

Voluntary: Firm initiated · Letter

Recall details

Manufacturer: ARROW INTERNATIONAL, LLC
Distributor: 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.
Lot: REF(Material)/UDI-DI/Lot(Batch): TJ-04020-1/10801902193275, 30801902202155/33F24J0338, 33F25A0158, 33F25C0753, 33F25E0281, 33F24B0409; NA-04220-S1A/10801902193275/33F25E1052, 33F24G0553; AK-04510-S/10801902192230, 10801902193275, 10801902196719/33F24A0337, 33F24A0338, 33F24A0339, 33F24A0341, 33F24A0342, 33F24A0343, 33F24A1012, 33F24B0107, 33F24B0108, 33F24B0109, 33F24B0110, 33F24B0111, 33F24C0010, 33F24C0011, 33F24D0015, 33F24D0016, 33F24E0046, 33F24E0047, 33F24G0327, 33F24G0570, 33F24G0571, 33F24G0572, 33F24G0573, 33F24G0574, 33F24G0575, 33F24J0493, 33F24J0674, 33F24J0675, 33F24J0676, 33F24J0677, 33F24K0091, 33F24K0309, 33F24K0313, 33F24L0623, 33F24L0627, 33F24L0629, 33F24L0631, 33F24L0754, 33F24L0783, 33F25A0457, 33F25A0613, 33F25A0614, 33F25A0615, 33F25A0616, 33F25C0738, 33F25C0751, 33F25C0794, 33F25C0846, 33F25C0907, 33F25C0955, 33F25C0956, 33F25E0040, 33F25E0288, 33F25E0289, 33F25E0290, 33F25E0910, 33F25E1065, 33F25E1066, 33F25G0079, 33F25G0158, 33F25H0012, 33F25H0193, 33F25H0194, 33F25H0195, 33F25H0196, 33F25J0464, 33F25J0642, 33F25J0789, 33F25J0801, 33F25J0802, 33F25J0803, 33F25J0804, 33F25L0486, 33F25L0488, 33F26B0668, 33F26B0669, 33F26B0671, 33F26B0672, 33F23L0360; ASK-04018-HUMC/10801902193275/33F25B0360, 33F25K0050, 33F25M0680, 33F25E1176; ASK-04018-OH1/10801902117622, 10801902193275, 10801902117622, 10801902117639/33F24F0741, 33F24L0218, 33F24L0865, 33F25B0173, 33F25C0253, 33F25E0667, 33F25F0162, 33F25J0143, 33F26A1440, 33F26B0794, 33F24A0112; ASK-04020-BID/10801902211429, 10801902193275, 10801902211429/33F24D0870, 33F24E0650, 33F24F0646, 33F24L0220, 33F24L0399, 33F25B0175, 33F25D0335, 33F25E0668, 33F25G0248, 33F25L0123, 33F26A0254, 33F26A1441, 33S23J0777, 33F24G0405; ASK-04020-MAR/10801902193275, 10801902159776/33F24J0567, 33F24L0586, 33F25A0519, 33F25E0136, 33F25E0979, 33F25G0675, 33F25J0504, 33F25L0210, 33F26B0742, 33F25K0032; ASK-04020-PM4/10801902138498, 10801902193275, 10801902138498, 30801902158896/33F24E0428, 33F24E0429, 33F24G0424, 33F24K0188, 33F24L0789, 33F25C0142, 33F25C0821, 33F25E0142, 33F25H0085, 33F25J0883, 33F25L0470, 33F26B0659, 33F24F0095; ASK-04120-HF3/10801902200447, 10801902193275, 10801902200447, 10801902117943/33F24D0857, 33F24F0638, 33F24H0168, 33F24K0389, 33F24L0289, 33F25D0336, 33F25F0126, 33F25F0163, 33F25H0616, 33F25J0202, 33F25M0158, 33F25M0362, 33F26A1429, 33F26B0127, 33S24A1516, 33S24C0854, 33F24A0136; ASK-04120-UR/10801902117943, 10801902193275, 10801902117943/33F24A0769, 33F24B0278, 33F24C0175, 33F24D0140, 33F24E0447, 33F24G0287, 33F24K0201, 33F25B0692, 33F25C0962, 33F25E0156, 33F25H0097, 33F25J0889, 33F25L0383, 33F26C0309, 33F24G0441; ASK-04125-MGH/10801902193275, 10801902139976/33F24J0584, 33F25C0985, 33F25D0307, 33F25E0157, 33F25E0990, 33F25H0098, 33F25J0519, 33F25L0421, 33F26A1057, 33F26B0983, 33F24K0203; ASK-04500-HFH4/10801902200461, 10801902193275, 10801902118001/33F24E0651, 33F24F0722, 33F24L0292, 33F25C0437, 33F25D0228, 33F25E0775, 33F25F0109, 33F25F0164, 33F25H0615, 33F25M0345, 33F26A1363, 33F26B0405, 33S24C0436, 33S24L0292, 33F24A0141; ASK-04510-BID2/10801902193275, 10801902211412, 10801902115024/33F24J0171, 33F25A0165, 33F25C0438, 33F25D0229, 33F25E0852, 33F25G0249, 33F25J0204, 33F25M0233, 33F26A1443, 33F26B0410, 33F24F0820; ASK-04510-EHP1/10801902193275, 10801902115024/33F24L0293, 33F25C0192, 33F25D0230, 33F25E0589, 33F25E0853, 33F25H0646, 33F25L0125, 33F26A0255, 33F26A1520, 33F26B0838, 33F24J0303; ASK-04510-FEM1/10801902214796, 10801902193275/33F24A0831, 33F24B0286, 33F24C0185, 33F24E0456, 33F24E0457, 33F24G0448, 33F24J0304, 33F24L0771, 33F25A0539, 33F25E0165, 33F25G0118, 33F25J0523, 33F26A1051, 33F26B0658, 33F24J0591; ASK-04510-HFH/10801902115031, 10801902193275, 10801902200454/33F24G0053, 33F24L0022, 33F24M0108, 33F24M0190, 33F25A0126, 33F25A0356, 33F25A0384, 33F25B0043, 33F25D0200, 33F25H0329, 33F25H0848, 33F25J0613, 33F26A1358, 33F26B0677, 33F24D0865; ASK-04510-HFH4/10801902200454, 10801902193275/33F24F0865, 33F24J0167, 33F24L0965, 33F25A0236, 33F2
Risk classification: Class I
Area (FDA): device
Country: United States

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