BEUDAMED
    FDA Enforcement Class I Ongoing

    Description/REF: ACCESS TRAY/GU-04020; PSI KIT: 8.5 FR/AK-09803-CDC; PSI KIT: 9 FR/AK-09903-CDC; PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-09810-PCMH1; PSI KIT: 9 FR X 10 CM/ASK-09903-KH; PSI KIT: 9 FR X 10 CM/ASK-09903-PHP1; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-09903-UPA; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-YNH; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09907-SL; PSI KIT: 8.5 FR X 4-1/8IN (10 CM)/NA-09803-CDC; PSI KIT: 9 FR X 4-1/8IN (10 CM)/NA-09903-CDC; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-09903-ECL4; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-MGH3; MULTI-LUMEN/PSI KIT/AK-11142-SPCS; MAC KIT: 2-L 9 FR DISTAL X 11.5 CM/CDC-11242-1A; MULTI-LUMEN/PSI KIT/AK-11142-D; MULTILUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-11142-MGH4; MULTI-LUMEN/PSI KIT/NA-11242-CDC; MULTI-LUMEN/PSI KIT/AK-21142-SK; MAC KIT: 2L 9 FR DISTAL X 10 CM AGB/ASK-21142-LMDTG; MULTI LUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-21142-RH; MULTILUMEN/PSI KIT 9 FR X 11.5 CM/ASK-21242-IMC; MAC KIT: 2L 9 FR DISTAL X 11.5 CM AGB/ASK-21242-LMDTG; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UMD; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UU3; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-VCU; MAC KIT: 2L 9 FR DISTAL X 11.5 CM AGB/CDC-21242-1A; MAC KIT: 2L 9 FR DISTAL X 11.5 CM AGB/CDC-21242-X1A; MULTI-LUMEN/PSI KIT/AK-21242-CDC; 2L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-FH4; MULTI LUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-21142-GH1; 2L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-SUU; 2-L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-UPMC4; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UKL; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UMF; MULTILUMEN/PSI KIT: 9 FR X 4 1/2 IN/ASK-21242-UR1; PSI KIT: 8.5 FR/AK-29803-CDC; PSI KIT: 9 FR/AK-29903-CDC; PSI KIT: 9 FR/AK-29907-CDC; PSI KIT: 8.5 FR X 4IN (10 CM)/ASK-09804-UN1; PSI KIT: 9 FR/ASK-09903-UM; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/ASK-29803-LMDT; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/ASK-29803-LMDTG; PSI KIT: 9 FR X 4 1/8 (10 CM)/ASK-29903-BID1; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-LMDTG; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-UMD; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-29903-UR1; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/CDC-29803-X1A; PSI KIT: 8.5 FR X 10 CM/ASK-29803-ECL; PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-29803-UPM3; PSI KIT: 9 FR X 10 CM/ASK-29903-ECL; PSI KIT: 9FR X 4IN (10 CM) ANTIMICROBIAL/ASK-29903-UPM3; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-09907-TG1

    Recall: Z-2385-2026 · Reported June 24, 2026

    Enforcement

    Recall Number
    Z-2385-2026
    Event ID
    98793
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ARROW INTERNATIONAL, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 24, 2026
    Initiation Date
    April 21, 2026
    Classification Date
    June 12, 2026
    Address
    3015 Carrington Mill Blvd, Morrisville, NC, 27560-5437, United States

    Description

    Description/REF: ACCESS TRAY/GU-04020; PSI KIT: 8.5 FR/AK-09803-CDC; PSI KIT: 9 FR/AK-09903-CDC; PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-09810-PCMH1; PSI KIT: 9 FR X 10 CM/ASK-09903-KH; PSI KIT: 9 FR X 10 CM/ASK-09903-PHP1; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-09903-UPA; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-YNH; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09907-SL; PSI KIT: 8.5 FR X 4-1/8IN (10 CM)/NA-09803-CDC; PSI KIT: 9 FR X 4-1/8IN (10 CM)/NA-09903-CDC; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-09903-ECL4; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-MGH3; MULTI-LUMEN/PSI KIT/AK-11142-SPCS; MAC KIT: 2-L 9 FR DISTAL X 11.5 CM/CDC-11242-1A; MULTI-LUMEN/PSI KIT/AK-11142-D; MULTILUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-11142-MGH4; MULTI-LUMEN/PSI KIT/NA-11242-CDC; MULTI-LUMEN/PSI KIT/AK-21142-SK; MAC KIT: 2L 9 FR DISTAL X 10 CM AGB/ASK-21142-LMDTG; MULTI LUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-21142-RH; MULTILUMEN/PSI KIT 9 FR X 11.5 CM/ASK-21242-IMC; MAC KIT: 2L 9 FR DISTAL X 11.5 CM AGB/ASK-21242-LMDTG; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UMD; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UU3; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-VCU; MAC KIT: 2L 9 FR DISTAL X 11.5 CM AGB/CDC-21242-1A; MAC KIT: 2L 9 FR DISTAL X 11.5 CM AGB/CDC-21242-X1A; MULTI-LUMEN/PSI KIT/AK-21242-CDC; 2L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-FH4; MULTI LUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-21142-GH1; 2L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-SUU; 2-L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-UPMC4; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UKL; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UMF; MULTILUMEN/PSI KIT: 9 FR X 4 1/2 IN/ASK-21242-UR1; PSI KIT: 8.5 FR/AK-29803-CDC; PSI KIT: 9 FR/AK-29903-CDC; PSI KIT: 9 FR/AK-29907-CDC; PSI KIT: 8.5 FR X 4IN (10 CM)/ASK-09804-UN1; PSI KIT: 9 FR/ASK-09903-UM; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/ASK-29803-LMDT; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/ASK-29803-LMDTG; PSI KIT: 9 FR X 4 1/8 (10 CM)/ASK-29903-BID1; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-LMDTG; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-UMD; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-29903-UR1; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/CDC-29803-X1A; PSI KIT: 8.5 FR X 10 CM/ASK-29803-ECL; PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-29803-UPM3; PSI KIT: 9 FR X 10 CM/ASK-29903-ECL; PSI KIT: 9FR X 4IN (10 CM) ANTIMICROBIAL/ASK-29903-UPM3; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-09907-TG1

    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 Info

    REF(Material)/UDI-DI/Lot(Batch): GU-04020/30801902118807, 10801902193275, 30801902118807, 30801902118807/33F24C0753, 33F24E0736, 33F24G0154, 33F24G0648, 33F24H0377, 33F25A0059, 33F25A0072, 33F25A0395, 33F25F0260, 33F25G0736, 33F25H0298, 33F25J0603, 33F26B0084, 33F26B0314, 33F26C0578, 33F24D0036; AK-09803-CDC/20801902121756, 10801902193275, 10801902117417/33F24B0126, 33F24B0127, 33F24C0021, 33F24D0021, 33F24E0072, 33F24G0338, 33F24G0587, 33F24J0506, 33F24K0105, 33F24L0722, 33F25A0468, 33F25C0107, 33F25C0953, 33F25E0054, 33F25E0921, 33F25G0086, 33F25H0023, 33F25J0828, 33F25K0255, 33F25K0364, 33F25L0328, 33F24A0239; AK-09903-CDC/10801902117417, 10801902193275, 20801902121916/33F24A0356, 33F24B0128, 33F24B0129,33F24C0022, 33F24D0022, 33F24E0074, 33F24E0075, 33F24G0340, 33F24G0588, 33F24J0507, 33F24K0107, 33F24L0676, 33F24L0759, 33F25A0470, 33F25C0108, 33F25C0730, 33F25E0056, 33F25E0923, 33F25H0025, 33F25J0471, 33F25K0031, 33F25L0237, 33F25M0920, 33F26A1053, 33F24A0386; ASK-09810-PCMH1/10801902193275/33F25K0051, 33F24J0109; ASK-09903-KH/10801902119350, 10801902193275/33F24D0713, 33F24K0385, 33F24L1060, 33F25D0340, 33F25E0778, 33F25H0567, 33F25M0163, 33F26A1407, 33F25E1184; ASK-09903-PHP1/10801902193275, 10801902115222/33F24J0115, 33F25H0497, 33F26A0410, 33F24F0625; ASK-09903-UPA/10801902193275, 10801902118193/33F24K0387, 33F24L0855, 33F24A0787; ASK-09903-YNH/10801902118193, 10801902193275, 10801902118209/33F24E0527, 33F24H0478, 33F24L0682, 33F25H0135, 33F25J0915, 33F24A0110; ASK-09907-SL/10801902118209, 10801902193275/33F24D0053, 33F24D0967, 33F24G0265, 33F25E0215, 33F25E0454, 33F25G0680, 33F25J0551, 33F25K0328, 33F25L0206, 33F26C0312, 33F25B0188; NA-09803-CDC/10801902119930, 10801902193275, 10801902119947/33F24C0756, 33F24E0739, 33F25A0342, 33F25J0615, 33F26B0028, 33F24A1327; NA-09903-CDC/10801902119947, 10801902193275, 10801902119954/33F24E0740, 33F24H0381, 33F24J0199, 33F24J0361, 33F24L0020, 33F25B0278, 33F25C0551, 33F25E0340, 33F25E0400, 33F25E0468, 33F25F0419, 33F25H0708, 33F26A1655, 33F26B0023, 33F24A0113; ASK-09903-ECL4/10801902193275, 10801902224344/33F26A1582, 33F26B0399, 33F25E0534; ASK-09903-MGH3/10801902193275, 10801902189841, 10801902212006/33F25C0264, 33F25G0338, 33F25J0360, 33F25K0130, 33F26B0126, 33F26C0004, 33F24D0780; AK-11142-SPCS/10801902196412, 10801902193275, 60801902123093/33F24A0382, 33F24A1019, 33F24C0024, 33F24E0078, 33F24E0154, 33F24G0343, 33F24J0510, 33F24K0110, 33F24L0673, 33F25A0472, 33F25C0381, 33F25C0389, 33F25C0952, 33F25E0059, 33F25H0027, 33F25J0831, 33F25K0302, 33F25L0365, 33F26B0514, 33S24J0510, 33F24D0075; CDC-11242-1A/60801902116736, 10801902193275, 40801902111768/33F24D0431, 33F24E0213, 33F24F0140, 33F24F0220, 33F24G0103, 33F24H0392, 33F24H0425, 33F24H0450, 33F24L0011, 33F25B0018, 33F25B0096, 33F25D0705, 33F25E1120, 33F25F0024, 33F25F0414, 33F25G0043, 33F25G0486, 33F25J0016, 33F25J0992, 33F25K0308, 33F25M0481, 33F24C1001; AK-11142-D/20801902121916, 10801902193275, 10801902196412/33F24A1018, 33F24C0023,33F24E0077, 33F24G0342,33F24J0509, 33F24K0109, 33F24L0615, 33F25A0471, 33F25C0842, 33F25E0058, 33F25G0088, 33F25J0472, 33F25K0301, 33F25L0467, 33F26B0593, 33F26B0958, 33F24A0252; ASK-11142-MGH4/10801902193275, 10801902189865, 10801902182545/33F25D0466, 33F25F0113, 33F25L0130, 33F25M0398, 33F26A1539, 33F26B0680, 33F24D0736; NA-11242-CDC/10801902119954, 10801902193275, 10801902119978/33F24A0817, 33F24A1218, 33F24B0399, 33F24C0270, 33F24G0554, 33F24J0663, 33F24L0743, 33F25C0197, 33F25C0870, 33F25E0273, 33F25H0179, 33F25H0761, 33F25L0419, 33F26B0562, 33F24C0271; AK-21142-SK/10801902193275, 30801902122248, 30801902122255/33F24G0356, 33F24G0589, 33F24J0520, 33F24K0122, 33F24L0670, 33F25A0480, 33F25C0720, 33F25E0071, 33F25H0030, 33F25J0837, 33F25L0473, 33F25M0964, 33F26A1097, 33F26B0956, 33R24L0670, 33F24D0023; ASK-21142-LMDTG/10801902193275/33F25K0417, 33F25F0007; ASK-21142-RH/10801902193275/10801902129953/33F24J0108, 33F24L0165, 33F24M0172, 33F25B0422, 33F25E1172, 33F25H0776, 33F25K0424, 33F26C0337, 33F25A0245; ASK-21242-IMC/10801902193275, 10801902118407/33F24G0500, 33F24J0631, 33F24K0255, 33F24L0609, 33F25A0572, 33F25E0223, 33F25H0142, 33F25J0921, 33F26B0543, 33F25C0696; ASK-21242-LMDTG/10801902193275, 10801902220827/33F25G0202, 33F25H0414, 33F25K0382, 33F25M0130, 33F26C0378, 33F24H0123; ASK-21242-UMD/10801902193275/33F24K0476, 33F24L0315, 33F25B0196, 33F25C0279, 33F25D0476, 33F25H0492, 33F25J0378, 33F25M0150, 33F26A1365, 33F25B0551; ASK-21242-UU3/10801902193275/33F24G0503, 33F24L0652, 33F25C0181, 33F25E0226, 33F25H0144, 33F25J0556, 33F24K0077; ASK-21242-VCU/10801902193275, 10801902112962/33F24K0694, 33F25G0171, 33F25H0495, 33F25J0379, 33F26C0494, 33F25C0439; CDC-21242-1A/50801902116821, 10801902193275/33F24D0486, 33F24D0981, 33F24E0227, 33F24F0175, 33F24G0104, 33F24H0296, 33F24H0305, 33F24H0331, 33F24H0357, 33F24H0393, 33F24H0427, 33F24M0019, 33F24M0055, 33F25A0131, 33F25A0367, 33F25B0019, 33F25C0511, 33F25D0706, 33F25E0417, 33F25E1122, 33F25F0416, 33F25G0066, 33F25G0476, 33F25G0711, 33F25H0852, 33F25J0964, 33F25K0352, 33F25L0229, 33F26A1614, 33F26A1624, 33F26A1649, 33F24H0332; CDC-21242-X1A/10801902193275, 30801902116834, 10801902196511/33F25J0291, 33F25J0672, 33F25J0678, 33F25J0690, 33F25J0700, 33F25J0708, 33F25J0724, 33F25L0067, 33F26A1616, 33F26A1625, 33F26B0642, 36F25B0014, 36F25E0020, 36F25G0029, 36F25H0016, 36F25J0005, 33F24C0518; AK-21242-CDC/30801902122255, 10801902193275, 30801902122262/33F24E0082, 33F24E0083, 33F24J0521, 33F24K0123, 33F24L0618, 33F25A0481, 33F25C0946, 33F25E0072, 33F25H0031, 33F25K0037, 33F25K0414, 33F25L0372, 33F26B0520, 33F26C0626, 33F24E0352; ASK-21142-FH4/10801902193275/33F24L0683; ASK-21142-GH1/10801902193275/33F25C0180, 33F25E1023, 33F25H0141, 33F25H0752, 33F25J0920, 33F25L0455, 33F25B0276; ASK-21142-SUU/10801902193275/33F25J0096, 33F25C0275; ASK-21142-UPMC4/10801902193275/33F25A0247; ASK-21242-UKL/10801902114065, 10801902193275, 10801902136487/33F24F0710, 33F24K0467, 33F24L0314, 33F25B0195, 33F25C0278, 33F25D0475, 33F25G0412, 33F25J0149, 33F25M0202, 33F26A1551, 33F26C0010, 33F26C0759, 33F24F0849; ASK-21242-UMF/10801902193275, 10801902129502/33F25D0477, 33F25H0487, 33F25J0150, 33F25K0096, 33F24D0715; ASK-21242-UR1/10801902193275, 10801902119435, 10801902118902/33F25E0225, 33F25J0555, 33F25L0427, 33F25M0928, 33F26C0261, 33F24E0542; AK-29803-CDC/10801902193275, 20801902117506/33F24G0378, 33F24J0283, 33F24J0533, 33F24K0141, 33F24L0620, 33F25A0488, 33F25C0901, 33F25E0090, 33F25G0095, 33F25H0039, 33F25J0487, 33F25L0389, 33F25M0893, 33F26A1021, 33F26B0537, 33F26C0262, 33F24G0379; AK-29903-CDC/10801902193275, 10801902117516, 10801902117523/33F24J0345, 33F24J0534, 33F24K0142,33F24L0672, 33F25A0489, 33F25C0904, 33F25E0091, 33F25G0096, 33F25H0040, 33F25J0488, 33F25L0382, 33F25M0889, 33F26B0533, 33F24D0091; AK-29907-CDC/10801902117523, 10801902193275/33F24E0377, 33F24J0535, 33F24L0606, 33F25C0122, 33F25C0854, 33F25E0092, 33F25H0041, 33F25J0848, 33F26B0503, 33F25A0146; ASK-09804-UN1/10801902193275, 10801902145847/33F25H0485, 33F26A0248, 33F24B0018; ASK-09903-UM/10801902193275, 10801902118186/33F25B0432, 33F25F0361, 33F25L0136, 33F24D0545; ASK-29803-LMDT/10801902193275, 10801902220810/33F25H0367, 33F25J0153, 33F25K0258, 33F25K0418, 33F26A1354, 33F26C0357, 33F25G0464; ASK-29803-LMDTG/10801902193275, 10801902220858/33F25H0413, 33F25H0585, 33F25K0207, 33F25K0419, 33F25M0198, 33F25M0440, 33F26C0170, 33F24G0607; ASK-29903-BID1/10801902193275/33F25K0066, 33F26A0251, 33F24H0139; ASK-29903-LMDTG/10801902193275, 10801902220735/33F25L0025, 33F25M0338, 33F26C0021, 33F24H0124; ASK-29903-UMD/10801902193275/33F25C0583, 33F26A0409, 33F24K0402; ASK-29903-UR1/10801902193275/33F25J0796, 33F24J0107; CDC-29803-X1A/10801902193275, 30801902117022, 10801902193114/33F25F0334, 33F25H0878, 33F25J0292, 33F25K0016, 33F25K0315, 33F25M0088, 33F26A1415, 33F26B0473, 36F25E0019, 36F25G0020, 36F25H0013, 33F24E0214; ASK-29803-ECL/10801902193275, 10801902200478/33F26A1576, 33F24D0625; ASK-29803-UPM3/10801902193275/33F25B0236; ASK-29903-ECL/10801902193275/33F26A1580, 33F25D0235; ASK-29903-UPM3/10801902193275/33F25J0558; ASK-09907-TG1/10801902118216/33F24D1025

    Distribution

    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.

    Quantity

    426,041