Description/REF: ACCESS TRAY/ASK-04001-JHH; ACCESS TRAY/ASK-04001-LMDTG; PI CVC KIT: 3 LUMEN 7 FR X 6 IN (16 CM)/ASK-12703-PSPH1; 3L CVC KIT: 7 FR X 16 CM/ASK-12703-WMC2; MULTILUMEN PI CVC KIT: 3L 7 FR X 20CM/ASK-15703-LMDT1; MULTILUMEN PI CVC KIT: 3L 7 FR X 20CM/ASK-15703-LMDTG1; MULTILUMEN PI CVC KIT: 3L 7 FR X 8 IN/ASK-15703-PVH; 1L CVC KIT: 16 GA X 8 IN (20CM)/ASK-24301-JHH1; CVC KIT: 16 GA X 16 CM/CDC-24306-1A; CVC KIT: 3-L 7 FR X 30 CM ANTIMICROBIAL/CDC-24703-X1A; LBCVC KIT: 3L 12 FR X 20 CM AGB/CDC-25123-1A; CVC KIT: 2L 8 FR X 6IN (16 CM)/ASK-42802-ECL3; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-ACH; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-BJC1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 16 CM/ASK-42703-DU1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-EMC; MULTI LUMEN PI CVC KIT: 3L 7 FR X 6IN/ASK-42703-LMDT1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-LMDTG1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-MCY1; MULTILUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-NS1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PAGP1; PI CVC KIT: 3L 7 FR X 6 IN (16 CM)/ASK-42703-PAM1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PAMC2; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PAU1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 16/ASK-42703-PB1; PI CVC KIT: 3L 7 FR X 16CM AGB+/ASK-42703-PBSWH2; MULTI LUMEN PI CVC KIT: 3L 7 FR X 16 IN/ASK-42703-PCAM1; MULTILUMEN PI CVC KIT: 3L 7 FR X 16 CM/ASK-42703-PCSJ2; MULTI LUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-PECL2; MULTI LUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-PGM4; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PHHN1; MULTI LUMEN CVC KIT: 3L 7 FR X 6 IN/ASK-42703-PLC; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PMEM; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PMHC1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNHS1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-POHU2; MULTILUMEN PI CVC KIT: 3L 7 FR X 6/ASK-42703-POSU2; MULTILUMEN CVC KIT 7 FR X 6 IN (16 CM)/ASK-42703-PTJH; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PUCH2; PI CVC KIT: 3L 7 FR X 6 IN (16 CM)

Class I

Recalling firm: ARROW INTERNATIONAL, LLC
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.
Affected products (lot / model / serial): REF(Material)/UDI-DI/Lot(Batch): ASK-04001-JHH/10801902193275/33F24K0748, 33F26A1669, 33F25G0558; ASK-04001-LMDTG/10801902193275, 10801902218442/33F26A0405, 33F24E0333; ASK-12703-PSPH1/10801902214338, 10801902193275, 10801902214338/33F24F0787, 33F24L0304, 33F25A0242, 33F25C0268, 33F25D0470, 33F25E0537, 33F25E0854, 33F25J0365, 33F25M0247, 33F26A1555, 33F26B0855, 33F26C0742, 33F24K0672; ASK-12703-WMC2/10801902193275/33F24K0493, 33F24L0305, 33F25B0156, 33F25E0593, 33F25H0483, 33F25J0367, 33F25M0218, 33F24K0545; ASK-15703-LMDT1/10801902193275/33F24J0164, 33F24L0307, 33F25B0192, 33F25C0230; ASK-15703-LMDTG1/10801902193275/33F25D0537, 33F25E0670, 33F25G0295, 33F25J0146, 33F25K0093, 33F25M0138, 33F26B0131, 33F25E0312; ASK-15703-PVH/10801902133226, 10801902193275, 10801902210217/33F24D0809, 33F24F0669, 33F24K0462, 33F24L0226, 33F25A0167, 33F25B0193, 33F25B0547, 33F25D0265, 33F25D0653, 33F25G0169, 33F25G0404, 33F25J0369, 33F26A1459, 33F24M0270; ASK-24301-JHH1/10801902193275, 10801902214819, 10801902210217/33F25A0170, 33F25B0552, 33F25E0547, 33F25G0222, 33F25L0056, 33F26B0421, 33F24E0546; CDC-24306-1A/30801902116919, 10801902193275, 30801902116919/33F24D0786, 33F24E0620, 33F24F0926, 33F24K0446, 33F24L0990, 33F25A0310, 33F25D0495, 33F25E0880, 33F25J0323, 33F26B0377, 33F26C0693, 33F24L1111; CDC-24703-X1A/10801902193275/33F25D0497, 33F25E0748, 33F25G0318, 33F25H0570, 33F25J0325, 33F26A1563, 33F25B0619; CDC-25123-1A/10801902193275, 10801902191622/33F24H0012, 33F24L0481, 33F25C0445, 33F25D0500, 33F25F0382, 33F25G0258, 33F26A1560, 33F26B0394, 33F25B0675; ASK-42802-ECL3/10801902193275/33F25E0567, 33F25F0128, 33F25H0464, 33F25J0286, 33F26A1399; ASK-42703-ACH/10801902193275, 30801902119514/33F24L0327, 33F24L1064, 33F25C0292, 33F25E0675, 33F25H0420, 33F25J0267, 33F25L0122, 33F25M0091, 33F26A1505, 33F24D0032; ASK-42703-BJC1/10801902193275, 10801902202519/33F24K0500, 33F24L0328, 33F25B0556, 33F25G0173, 33F25J0268, 33F26A1513, 33F26B0767, 33F25C0744; ASK-42703-DU1/10801902193275, 1080190216099/33F25B0141, 33F25C0232, 33F25E0786, 33F25J0105, 33F25M0014, 33F26C0342, 33F24F0060; ASK-42703-EMC/10801902160475, 10801902118421/33F24F0881, 33F25A0214, 33F25C0293, 33F25D0596, 33F25H0632, 33F25M0115, 33F26C0343, 33F24F0132; ASK-42703-LMDT1/10801902205657, 10801902193275/33F24F0688, 33F24J0157, 33F24L0228, 33F24L0329, 33F24L1096, 33F25A0252, 33F25B0557, 33F25C0352, 33F25E0557, 33F25E0722, 33F25G0400, 33F25K0139, 33F26A1370, 33F26B0210, 33F25C0294; ASK-42703-LMDTG1/10801902193275, 10801902205695, 10801902220896/33F25E0558, 33F25E0860, 33F25G0271, 33F25G0399, 33F25H0419, 33F26B0387, 33F24G0070; ASK-42703-MCY1/10801902193275, 0801902220896/33F24H0198, 33F24K0425, 33F25A0198, 33F25B0651, 33F25C0353, 33F25D0405, 33F25E0676, 33F25H0452, 33F25J0220, 33F25M0183, 33F26A1479, 33F26B0863, 33F25H0409; ASK-42703-NS1/10801902193275, 10801902216479/33F25A0300, 33F25B0652, 33F25C0375, 33F25E0723, 33F25H0459, 33F25J0221, 33F26A1579, 33F26B0825, 33F25C0354; ASK-42703-PAGP1/10801902193275, 10801902158717, 10801902136685/33F25D0406, 33F25E0560, 33F25E0790, 33F25H0560, 33F25L0114, 33F26A1353, 33F26A1506, 33F26B0751, 33F24D0181; ASK-42703-PAM1/10801902136685, 10801902193275/33F24E0310, 33F24L0895, 33F25A0256, 33F25B0496, 33F25C0477; ASK-42703-PAMC2/10801902193275, 10801902217131/33F25F0188, 33F25J0270, 33F26C0161, 33F24K0400; ASK-42703-PAU1/10801902193275/33F24L0414, 33F25B0143, 33F25C0474, 33F25G0397, 33F25M0313, 33F26A1349, 33F25B0232; ASK-42703-PB1/10801902193275, 10801902220377/33F25E0458, 33F25K0427, 33F24F0065; ASK-42703-PBSWH2/10801902220377, 10801902193275, 10801902220377, 10801902203189/33F24F0651, 33F24K0368, 33F24L0230, 33F24L0415, 33F24L1079, 33F25B0167, 33F25C0440, 33F25D0539, 33F25E0014, 33F25E0596, 33F25G0205, 33F25H0511, 33F25J0222, 33F25K0112, 33F25M0394, 33F26B0412, 33F24D0720; ASK-42703-PCAM1/10801902203189, 10801902193275, 10801902141030/33F24F0675, 33F24L1058, 33F25B0560, 33F25C0355, 33F25D0351, 33F25E0725, 33F25G0366, 33F25J0386, 33F2
Units affected: 1,061,069
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.
Firm location: Morrisville, NC, United States
Recall type: Voluntary: Firm initiated
How the firm notified customers: Letter
Product type: Devices
Status: Ongoing
Recall number: Z-2384-2026
Recall initiated: April 21, 2026
FDA classification date: June 12, 2026
FDA report date: June 24, 2026
FDA event ID: 98793
Last updated on HTM Vibe: July 23, 2026

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