FDAFDA · Food and drugs·Recall number Z-2388-2026

Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 20 CM/AK-15122-F, AHDC KIT: 3L 12 FR X 16 CM/ASK-12123-UOC1, AHDC KIT: 3-L 12 FR X 16 CM/ASK-12123-UPM, AHDC KIT: 3L 12 FR X 20 CM/ASK-15123-UOC1, AHDC KIT: 3-L 12 FR X 20 CM/ASK-15123-UPM, AHDC KIT: 3-L 12 FR X 16 CM/CDC-12123-P1A, AHDC KIT: 3-L 12 FR X 16 CM/CDC-12123-XP1A, AHDC KIT: 3-L 12 FR X 16 CM/CDC-12123-XPCN1A, AHDC KIT: 3-L 12 FR X 16 CM/CDC-12123-XPN1A, AHDC KIT: 3-L 12 FR X 20 CM/CDC-15123-P1A, AHDC KIT: 3-L 12 FR X 20 CM/CDC-15123-XPCN1A, AHDC KIT: 3-L 12 FR X 20 CM/CDC-15123-XPN1A, AHDC KIT: 3-L 12 FR X 25 CM/CDC-16123-XPCN1A, HEMODIALYSIS KIT 2L: 12 FR X 20CM AGB/AK-25122-CDC, HEMODIALYSIS KIT: 2-LUMEN 14 FR X 20 CM/AK-25142-F, HEMODIALYSIS KIT: 2L 12 FR X 6 IN/ASK-22122-MM1, HEMODIALYSIS KIT: 2L 12 FR X 6 IN/ASK-22122-MM2, AHDC KIT: 2L 14 FR X 15 CM/ASK-22142-UOC1, AHDC AGB KIT: 2-L 14 FR X 15 CM/ASK-22142-UPM, HEMODIALYSIS KIT: 2L 14 FR X 20 CM/ASK-25142-UNC1, AHDC KIT: 2L 14 FR X 20 CM/ASK-25142-UOC1, AHDC AGB KIT: 2L 14 FR X 20 CM/ASK-25142-UPM, HEMODIALYSIS KIT 2L: 14 FR X 25 CM AGB/ASK-26142-UNC1, HEMODIALYSIS KIT: 2LUMEN 12 FR X 16 CM/AU-22122-F, HEMODIALYSIS KIT: 2L 12 FR X 16 CM AGB/CDC-22122-1A, AHDC AGB U-BEND KIT: 2-L 12 FR X 16 CM/CDC-22122-XCN1A-U, AHDC AGB KIT: 2-L 12 FR X 16 CM/CDC-22122-XN1A, AHDC AGB U-BEND KIT: 2-L 12 FR X 16 CM/CDC-22122-XN1A-U, HEMODIALYSIS KIT 2L: 14 FR X 15 CM AGB/CDC-22142-1A, HEMODIALYSIS KIT: 2L 14 FR X 15 CM AGB/CDC-22142-XC1A, AHDC AGB KIT: 2-L 14 FR X 15 CM/CDC-22142-XCN1A, AHDC AGB CURVED KIT: 2-L 14 FR X 15 CM/CDC-22142-XCN1A-C, AHDC AGB KIT: 2-L 14 FR X 15 CM/CDC-22142-XN1A, AHDC AGB CURVED KIT: 2-L 14 FR X 15 CM/CDC-22142-XN1A-C, AHDC AGB U-BEND KIT: 2-L 12 FR X 13 CM/CDC-23122-XCN1A-U, AHDC AGB U-BEND KIT: 2-L 12 FR X 13 CM/CDC-23122-XN1A-U, HEMODIALYSIS KIT: 2L 12 FR X 13 CM AGB/CDC-23122-XU1A, HEMODIALYSIS KIT: 2L 12 FR X 20 CM AGB/CDC-25122-1A, HEMODIALYSIS KIT: 2L 12 FR X 20 CM AGB/CDC-25122-X1A, AHDC AGB KIT: 2-L 12 FR X 20 CM/CDC-25122-XCN1A, AHDC AGB U-BEND KIT: 2-L 12 FR X 20 CM/CDC-25122-XCN1A-U, AHDC AGB KIT: 2-L 12 FR X 20 CM/CDC-25122-XN1A, HEMODIALYSIS KIT: 2L 12 FR X 20 CM AGB/CDC-25122-XU1A, HEMODIALYSIS KIT 2L: 14 FR X 20 CM AGB/CDC-25142-1A, HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB/CDC-25142-XC1A, AHDC AGB KIT: 2-L 14 FR X 20 CM/CDC-25142-XCN1A, AHDC AGB CURVED KIT: 2-L 14 FR X 20 CM/CDC-25142-XCN1A-C, AHDC AGB KIT: 2-L 14 FR X 20 CM/CDC-25142-XN1A, AHDC AGB CURVED KIT: 2-L 14 FR X 20 CM/CDC-25142-XN1A-C, HEMODIALYSIS KIT: 2L 12 FR X 25 CM AGB/CDC-26122-1A, AHDC AGB KIT: 2-L 12 FR X 25 CM/CDC-26122-XCN1A, AHDC AGB KIT: 2-L 12 FR X 25 CM/CDC-26122-XN1A, HEMODIALYSIS KIT 2L: 14 FR X 25 CM AGB/CDC-26142-1A, HEMODIALYSIS KIT: 2L 14 FR X 25 CM AGB/CDC-26142-X1A, AHDC AGB KIT: 2-L 14 FR X 25 CM/CDC-26142-XCN1A, AHDC AGB KIT: 2-L 14 FR X 25 CM/CDC-26142-XN1A, HEMODIALYSIS KIT: 2-LUMEN 12 FR X 20 CM/AK-25122-F, AHDC AGB KIT: 2-L 12 FR X 16 CM/CDC-22122-XCN1A, LBCVC AGB KIT: 3-L 12 FR X 16 CM/CDC-22123-XCN1A, LBCVC AGB KIT: 3-L 12 FR X 20 CM/CDC-25123-XCN1A, LBCVC AGB KIT:3-L 12 FR X 20 CM/CDC-25123-XN1A

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): AK-15122-F/10801902197136, 10801902193275, 10801902168525/33F24E0348, 33F24J0280, 33F24K0119, 33F24L0601, 33F25A0477, 33F25C0908, 33F24A0850; ASK-12123-UOC1/10801902193275/33F25B0430, 33F25D0119; ASK-12123-UPM/10801902193275, 10801902222463/33F25E0535, 33F25G0188, 33F25G0189, 33F26C0333, 33F25D0262; ASK-15123-UOC1/10801902193275/33F25C0378, 33F25D0121; ASK-15123-UPM/10801902193275, 10801902159950/33F25E0718, 33F25H0447, 33F26A1389, 33F24E0649; CDC-12123-P1A/40801902111768, 10801902193275/33F24D0632, 33F24F0758, 33F24L0465, 33F25A0281, 33F25E0794; CDC-12123-XP1A/10801902193275, 30801902111785, 10801902213416/33F25J0723, 33F26A1382, 33F26B0433, 36F25A0007, 36F25B0009, 36F25E0018, 33F24D0299; CDC-12123-XPCN1A/10801902213416, 10801902193275/33F24D0950, 33F24K0417, 33F24L0466, 33F25A0216, 33F25B0667, 33F25D0436, 33F25D0666, 33F25E0693, 33F25G0239, 33F25J0247, 33F26A1556, 33F26B0801, 33F26C0767, 33F25B0668; CDC-12123-XPN1A/10801902193275, 10801902213409/33F25D0554, 33F25G0240, 33F25J0312, 33F26B0214,33F26C0199, 33F25A0181; CDC-15123-P1A/10801902193275/33F25D0437, 33F25H0547,33F25B0613; CDC-15123-XPCN1A/10801902213430, 10801902193275/33F24F0107, 33F24F0998, 33F24K0403, 33F24L0834, 33F25A0283, 33F25B0527, 33F25E0650, 33F25E0745, 33F25F0085, 33F25H0596, 33F25J0314, 33F26A1464, 33F26B0883, 33F25B0669; CDC-15123-XPN1A/0801902193275, 10801902213423, 10801902116793/33F25D0439, 33F25G0238, 33F25H0597, 33F25J0315, 33F26A1468, 33F26B0826, 33F24C0461; CDC-16123-XPCN1A/10801902193275/33F25B0671, 33F25D0440, 33F25E0651, 33F25G0236, 33F25H0529, 33F25J0316, 33F25G0237, AK-25122-CDC/10801902193275/33F24G0370, 33F24K0135, 33F25C0120, 33F25C0969, 33F25E0942, 33F24G0371; AK-25142-F/10801902193275, 70801902123205, 10801902167795/33F25C0863, 33F25E0087, 33F25H0038, 33F25J0846, 33F26B0531, 33F24D0089; ASK-22122-MM1/10801902193275/33F25E0546; ASK-22122-MM2/10801902193275, 10801902221923, 10801902144956/33F25G0172, 33F25L0031, 33F25M0310, 33F26A1652, 33F26B0151, 33F26B0450, 33F24F0854; ASK-22142-UOC1/10801902193275/33F25C0545, 33F25D0122; ASK-22142-UPM/10801902193275, 10801902222487, 10801902202281/33F25D0594, 33F25F0116, 33F25G0187, 33F26A1390, 33F26B0205, 33F24D0396; ASK-25142-UNC1/10801902193275/33F25C0655, 33F24K0561; ASK-25142-UOC1/10801902193275/33F25B0362, 33F25D0123; ASK-25142-UPM/10801902193275/33F25E0595, 33F25H0446, 33F25J0381, 33F26A1446, 33F25J0092; ASK-26142-UNC1/10801902193275/33F25B0427, 33F25K0058; AU-22122-F/10801902193275/33F24K0269, 33F25A0584, 33F25C0862, 33F25E0245, 33F25J0567; CDC-22122-1A/20801902123484, 10801902193275/, CDC-22122-XCN1A-U/33F24F0996, 33F24L0374, 33F25C0461; CDC-22122-XN1A/10801902193275/33F25C0239, 33F25E0875, 33F25J0419; CDC-22122-XN1A-U/10801902193275, 10801902213621/33F25A0309, 33F25E0876, 33F26B0217; CDC-22142-1A/50801902123515, 10801902193275/33F24D0928, 33F24F0103, 33F24F0896, 33F24L0111, 33F24L0955, 33F25B0500, 33F25D0447, 33F25E0654, 33F25G0278, 33F25H0577, 33F25J0319; CDC-22142-XC1A/10801902193275/33F25A0284, 33F25J0180; CDC-22142-XCN1A/10801902193275, 10801902213539/33F25A0285, 33F25B0529, 33F25D0449, 33F25E0655, 33F25E0818, 33F25F0214, 33F25G0233, 33F26A1477, 33F26B0898, 33R25J0455; CDC-22142-XCN1A-C/10801902193275/33F24L0473, 33F25B0615, 33F25F0213; CDC-22142-XN1A/10801902193275, 10801902213522/33F25C0240, 33F25E0578, 33F25F0215, 33F25H0528, 33F25J0321, 33F26A1383, 33F26B0215, 33F26C0016; CDC-22142-XN1A-C/10801902193275/33F25B0485, 33F25E0879; CDC-23122-XCN1A-U/10801902193275/33F24L0279, 33F25D0492; CDC-23122-XN1A-U/10801902193275/33F25E0579; CDC-23122-XU1A/10801902193275/33F25D0493, 33F25H0432, 33F25J0248; CDC-25122-1A/10801902193275/33F25B0619, 33F25E0881; CDC-25122-X1A/10801902193275/33F25E0882, 33F25J0422; CDC-25122-XCN1A/10801902213492, 10801902193275/33F24F0929, 33F25C0242, 33F25D0498, 33F25E0883, 33F25G0234, 33F26B0439, 33F26C0214; CDC-25122-XCN1A-U/10801902193275/33F24L1041, 33F25B0620, 33F25F0121, 33F25G0226; CDC-25122-XN1A
Risk classification: Class I
Area (FDA): device
Country: United States

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