FDAClass I · Medical device · Recalled June 24, 2026

Description/REF recall — ARROW INTERNATIONAL, LLC

View the official FDA enforcement record (openFDA) ↗

Official recall ID

Z-2394-2026

Brand

ARROW INTERNATIONAL

Classification

Class I

Units affected

177,014

Recall status

Ongoing

Initiated

Voluntary: Firm initiated

Description

Description/REF: MIDLINE CATHETER KIT: 3 FR X 20 CM/CDC-02031-MK1A; AM/AT PI MIDLINE 1L: 4.5FR X 15CM/CDC-41541-MPK1A; AM/AT PI MIDLINE 2L: 5.5FR X 15CM/CDC-41552-MPK1A; AGBA PI MIDLINE 1L: 4.5FR X 15CM/ASK-41541-VFHM; AGBA PI MIDLINE 1-L: 4.5FR X 15CM/CDC-41541-MPK; AGBA PI MIDLINE 1-L: 4.5FR X 15CM/CDC-41541-MPKB; AGBA PI MIDLINE 1-L: 4.5FR X 15CM/CDC-41541-MPKC; AGBA PI MIDLINE 2-L: 5.5FR X 15CM/CDC-41552-MPK; AGBA PI MIDLINE 2-L: 5.5FR X 15CM/CDC-41552-MPKB; AGBA PI MIDLINE 2-L: 5.5FR X 15CM/CDC-41552-MPKC; PI MIDLINE 1-L: 4FR X 20CM/CDC-32041-MPK; PI MIDLINE 1-L: 4FR X 20CM/CDC-32041-MPKB; PI MIDLINE 1L: 4FR X 20CM/CDC-32041-MPKC; PI MIDLINE 2-L: 5FR X 20CM/CDC-32052-MPKB; PI PICC NaviCurve: 1L 4FR x 55CM w BP/DLX-35541-CURVB; PI PICC: 1L 4FR x 55CM w Biopatch/DLX-35541-HPKB; PI PICC: 1L 4FR x 55CM w CHG/DLX-35541-HPKC; PI PICC: 2L 5FR x 55CM w Biopatch/DLX-35552-HPKB; PI PICC: 2L 5FR X 55CM w CHG/DLX-35552-HPKC; PI PICC: 3L 6FR x 55CM w Biopatch/DLX-35563-HPKB; AGBA PICC/DELTA KIT: 1L 4.5 FR X 40 CM/ASK-44041-NS; AGBA PICC/DELTA FG: 2L 5.5 FR X 40 CM/ASK-44052-NS; AGBA PICC/DELTA KIT: 1L 4.5 FR X 50 CM/ASK-45041-NS; PI PICC KIT: 2L 5.5 FR X 50 CM/ASK-45052-TG; PI AGBA PICC KIT: 3L 6 FR X 50 CM W/VPS/ASK-45063-NS; PICC KIT: 1L 4.5 FR X 55 CM CG+ VPS/ASK-45541-RH; AGBA PICC: 1L 4.5FR x 55CM w Teg CHG/DLX-45541-HPKC; AGBA PICC: 2L 5.5FR x 55CM w Teg CHG/DLX-45552-HPKC; AGBA PICC NaviCurve: 3L 6FR x 55CM TCG/DLX-45563-CURVC; AGBA PICC: 3L 6FR x 55CM w Biopatch/DLX-45563-HPKB; AGBA PICC: 3L 6FR x 55CM w Teg CHG/DLX-45563-HPKC; PI PICC KIT: 1-L 4 FR X 55 CM TIPTRACKER/CDC-35541-TTS; PI PICC NaviCurve: 1L 4FR x 55CM w CHG/DLX-35541-CURVC; PI PICC G4 Stylet: 1L 4FR x 55CM w BP/DLX-35541-VPSB; PI PICC NaviCurve: 2L 5FR x 55CM w CHG/DLX-35552-CURVC; PI PICC G4 Stylet: 2L 5FR x 55CM w BP/DLX-35552-VPSB; PI PICC G4 Stylet: 2L 5FR x 55CM w CHG/DLX-35552-VPSC; PI PICC NaviCurve: 3L 6FR x 55CM w CHG/DLX-35563-CURVC; PI PICC G4 Stylet: 3L 6FR x 55CM w CHG/DLX-35563-VPSC; AGBA PICC/DELTA KIT: 1-L 4.5 FR X 40 CM/CDC-44041-VPS2; PICC KIT: 1L 4.5 FR X 55 CM VPS/ASK-45541-UWH1; PI AGBA PICC KIT: 2L 5.5FR X 55CM W/ VPS/ASK-45552-UWH1; AGBA PICC G4 Stylet: 1L 4.5FR x 55CM BP/DLX-45541-VPSB; ACCESS TRAY/ASK-04001-NWM; ACCESS TRAY/ASK-04001-VCUH3; PI PICC:1L 4FR X 40CM PRELOAD VPS STYLET/CDC-34041-VPS; PI PICC:2L 5FR X 50CM PRELOAD VPS STYLET/CDC-35052-VPS; ACCESS KIT/ASK-04001-BWK2; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-DU11; MULTI LUMEN PI CVC KIT: 3L 7 FR X 6 IN/ASK-42703-PVD; MULTI LUMEN PI CVC KIT: 3L 7 FR X 16CM/ASK-12703-LMDTG1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 8IN/ASK-15703-ECMC4; MULTI LUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-15703-PNM; CVC KIT: 3 LUMEN 12 FR X 6IN/ASK-22123-UAB; 2-L CVC KIT: 4 FR X13 CM/CDC-24402-X1A; LBCVC KIT: 3L 12 FR X 20 CM AGB/CDC-25123-X1A; CVC KIT: 3L 7 FR X 16 CM/ASK-42703-CPR; CVC KIT: 2L 8 FR X 6 IN (16 CM) AGB+/ASK-42802-DMC2; CVC KIT: 2 LUMEN 8 FR X 8 IN (20 CM)/ASK-45802-PCMH1; PI CVC KIT: 3L 7 FR X 6 IN (16 CM) AGB+/ASK-42703-MM1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PHUMC1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PMSG1; MULTILUMEN PI CVC KIT: 3L 7 FR X 6/ASK-42703-POSU3; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PSAU1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-RHR1; PI CATHETER 2L: 8 FR X 16 CM AGB+/ASK-42802-DU1; PI CVC KIT: 2L 8 FR X 6 IN/ASK-42802-PHF4; PI CVC KIT: 2L 8 FR X 16 CM AGB+/ASK-42802-PHHN1; MULTILUMEN CVC KIT: 2L 8 FR X 6 IN/ASK-42802-POSU3; PI CVC KIT: 2-L 8 FR X 16 CM AGB+/ASK-42802-PUCD1; MULTI-LUMEN CVC KIT:2-L 8FR X 6IN (16CM)/ASK-42802-PWHC1; PI CVC KIT: 2L 8 FR X 16 CM AGB+/ASK-42802-UHC; PI CVC KIT: 4L 8.5 FR X 16 CM AGB+/ASK-42854-MCY1; PI CVC KIT: 3L 7FR X 8IN (20 CM) AGB+/ASK-45703-BCH; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-EMC; PI CVC KIT: 3 LUMEN 7 FR X 8 IN (20 CM)/ASK-45703-MHMC1; PI CVC KIT: 3-L 7 FR X 20 CM AGB+/ASK-45703-NWM; MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PCOR; MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PIMH; MULTI LUMEN CVC KIT: 3L

Affected products

• Description/REF

Companies & origin

Recalling firm location

Morrisville, NC, United States

Firm address

3015 Carrington Mill Blvd, 27560-5437

Identifying details (verbatim from the notice)

Product codes / lots

REF(Material)/UDI-DI/Lot(Batch): CDC-02031-MK1A/10801902193275/33F25C0444; CDC-41541-MPK1A/10801902193275/33F24L1137; CDC-41552-MPK1A/10801902193275, 50801902130162/33F24L0382, 33F25A0315, 33F25B0630, 33F25K0421, 33S24B0571; ASK-41541-VFHM/10801902193275, 10801902218862/33F24L1080, 33F25B0475, 33F25C0351, 33F25D0404, 33F25E0556, 33F25E0784, 33F25F0186, 33F25J0218, 33F25K0077, 33F25K0100, 33F25M0182, 33F26A1549, 33F26B0823; CDC-41541-MPK/10801902193275, 10801902193275/33F25H0768, 33S23K0382; CDC-41541-MPKB/10801902193275, 10801902205411/33F24H0429, 33F24K0043, 33F24M0067, 33F24M0149, 33F25A0390, 33F25B0099, 33F25B0343, 33F25C0578, 33F25E0421, 33F25F0401, 33F25G0515, 33F25G0710, 33F25H0817, 33F25J1008, 33F25L0015, 33F25L0050, 33F25L0295, 33F25M0499, 33F26A0330, 33X25J0003; CDC-41541-MPKC/10801902205435, 10801902193275/33F24D0982, 33F24F0166, 33F24F0167, 33F24H0398, 33F24H0454, 33F24J0380, 33F24J0389, 33F24K0581, 33F24L0182, 33F24M0022, 33F24M0077, 33F25A0348, 33F25B0228, 33F25B0281, 33F25B0289, 33F25B0344, 33F25C0513, 33F25C0532, 33F25C0558, 33F25D0710, 33F25D0736, 33F25F0020, 33F25F0025, 33F25F0032, 33F25H0818, 33F25J0577, 33F25J0657, 33F25L0251, 33F25L0296, 33S25A0211, 33F26C0435; CDC-41552-MPK/10801902201505/33F24D0561, 33F26B0490, 33S24A0521; CDC-41552-MPKB/10801902193275, 10801902205428/33F24J0183, 33F24J0221, 33F24L0010, 33F24L0173, 33F24M0114, 33F25B0223, 33F25B0299, 33F25D0724, 33F25F0436, 33F25G0640, 33F25K0354, 33F25L0265, 33F26B1048; CDC-41552-MPKC/10801902205442, 10801902193275/33F24C0861, 33F24D0343, 33F24F0090, 33F24K0474, 33F25C0208, 33F25D0559, 33F25E0827, 33F25H0608, 33F25J0434, 33F25M0248, 33F26A1559, 33F26C0776; CDC-32041-MPK/10801902193275, 10801902201475/33F25C0701, 33F25H0613, 33F25J0433, 33F25L0115, 33F25M0250, 33F26B0436; CDC-32041-MPKB/10801902205398, 10801902193275/33F24D0854, 33F24F0897, 33F24L0952, 33F25B0502, 33F25D0512, 33F25E0825, 33F25G0327, 33F25J0327, 33F25M0210, 33F26B0434, 33S23E0870; CDC-32041-MPKC/10801902193275/33F25D0513, 33F25H0590, 33F26A1387; CDC-32052-MPKB/10801902205404, 10801902193275/33F24F0825, 33F24L0381, 33F25D0514, 33F25H0609; DLX-35541-CURVB/10801902193275, 10801902208757/33F25D0674, 33F25J0186, 33S23G0883, 33S23H0988; DLX-35541-HPKB/10801902193275/33F25D0129, 33F25E0708; DLX-35541-HPKC/10801902193275/33F25D0244, 33F25E0830; DLX-35552-HPKB/10801902193275/33F25D0246, 33F25D0518, 33F25F0149; DLX-35552-HPKC/10801902193275, 10801902216721/33F25D0247, 33F25D0519, 33F25H0460, 33S23K0380; DLX-35563-HPKB/10801902193275/33F25K0318; ASK-44041-NS/10801902193275, 10801902216462/33F24L0347, 33S23H0298; ASK-44052-NS/10801902193275, 10801902216455/33F25A0302, 33S23J0265; ASK-45041-NS/10801902216677/33S24A0529; ASK-45052-TG/10801902193275/33F24L0864, 33F25D0409, 33F25H0490, 33F26A1379; ASK-45063-NS/10801902193275/33F24L1002; ASK-45541-RH/10801902193275/33F25B0574, 33F25E0607, 33F25H0427, 33F25J0161, 33F26A1412; DLX-45541-HPKC/10801902208849, 10801902193275/33F24D0604, 33F25D0128, 33F25E0763, 33F25J0131, 33F25M0315, 33F26B0456; DLX-45552-HPKC/10801902208856, 10801902193275/33F24F0097, 33F25C0450, 33F25D0252, 33F25D0625, 33F25G0321, 33F25H0601, 33F26B0213; DLX-45563-CURVC/10801902193275, 10801902208740/33F25A0321, 33F25B0635, 33F25D0522, 33F25E0766, 33F25G0394, 33F26C0707; DLX-45563-HPKB/10801902193275/33F25D0384, 33F25F0226; DLX-45563-HPKC/10801902208863, 10801902193275/33F24D0184, 33F25B0698, 33F25E0661, 33F26A1545; CDC-35541-TTS/10801902193275/33F25B0468; DLX-35541-CURVC/10801902193275, 10801902216684/33F25D0574, 33F25E0759, 33F25G0216, 33F25H0591, 33F25M0200, 33F26B0192; DLX-35541-VPSB/10801902193275, 10801902208665/33F25C0212, 33F25D0378, 33F25E0831, 33F25F0101, 33F25G0364, 33F25J0128, 33F25J0256, 33F25K0193, 33F25M0164, 33F26A1131, 33F26B0180, 33F26C0699; DLX-35552-CURVC/10801902193275, 10801902216714/33F25C0373, 33F25D0619, 33F25F0222, 33S24C0282; DLX-35552-VPSB/10801902193275, 10801902208672/33F25B0536, 33F25D0248, 33F25D0379, 33F25D0575, 33F25H0471, 33F25H0603, 33F26C0042; DLX-35552-VPSC/10801902193275, 10801902216738/33F25B0389, 33F25D0249, 33F25J0122, 33F25J0335, 33F25M0445, 33F26A0470, 33S24B0733; DLX-35563-CURVC/10801902193275, 10801902216745/DLX-35563-CURVC, DLX-35563-CURVC, DLX-35563-CURVC; DLX-35563-VPSC/10801902193275, 10801902216769/33F25C0395, 33F26B0380; CDC-44041-VPS2/10801902193275, 50801902120699/33F24K0430, 33S23L0922; ASK-45541-UWH1/10801902193275, 10801902217216/33F24L0991, 33F25C0198, 33F25E0572, 33F25H0457, 33F25J0400, 33F25M0151, 33F26B0384; ASK-45552-UWH1/10801902193275/33F24L0431, 33F25B0576, 33F25G0212, 33F25H0589, 33F25J0225, 33F25M0229, 33F26A1554; DLX-45541-VPSB/10801902193275, 10801902208603/33F24L1122, 33F25B0679, 33F25D0064, 33F25D0521, 33F25H0403, 33F25H0605, 33F26C0119; ASK-04001-NWM/10801902193275, 10801902222715/33F25F0005, 33F25F0125, 33F26A1493, 33F26B0829; ASK-04001-VCUH3/10801902214895, 10801902193275/33F24D0895, 33F24F0785, 33F24L1087, 33F25B0172, 33F25F0161, 33F25G0221, 33F25H0522, 33F25J0198, 33F26B0228, 33F26B0831, 33F26C0534; CDC-34041-VPS/10801902193275/33F24L0236; CDC-35052-VPS/10801902193275/33F25E0425; ASK-04001-BWK2/10801902193275/33F25A0226, 33F25D0389, 33F25E0519, 33F25F0076, 33F25F0139, 33F25H0660, 33F25J0347, 33F26A1341; ASK-04001-DU11/10801902193275/33F25C0425, 33F25D0328, 33F25F0140, 33F25H0506; ASK-42703-PVD/10801902156966, 10801902193275/33F24F0977, 33F24L1004, 33F25C0302, 33F25K0144, 33F26B0157; ASK-12703-LMDTG1/10801902193275, 10801902205688/33F25D0262, 33F25G0280, 33F26B0212; ASK-15703-ECMC4/10801902159950, 10801902193275/33F24E0649, 33F24F1039, 33F25B0439; ASK-15703-PNM/10801902193275/33F25E0312; ASK-22123-UAB/10801902144956, 10801902193275/33F24F0854, 33F24L0318, 33F25C0281, 33F25D0267, 33F25D0593, 33F25J0380; CDC-24402-X1A/10801902193275, 10801902168099/33F24L1111, 33F25C0206, 33F25E0747, 33F25G0341, 33F25H0554, 33F25J0324, 33F26A1561, 33F26B0165, 33F26B0803; CDC-25123-X1A/10801902193275, 10801902168105/33F25B0675, 33F25D0501, 33F25E0887, 33F25G0379, 33F26A1562, 33F26B0892; ASK-42703-CPR/10801902193275, 10801902135220/33F25C0744, 33F25E0234, 33F25J0559, 33F25J0797, 33F25K0401, 33F26B0244; ASK-42802-DMC2/10801902193275/33F25E0005; ASK-45802-PCMH1/10801902193275/33F25D0034; ASK-42703-MM1/10801902193275, 10801902221916/33F25E0509, 33F25E0559, 33F25M0205, 33F25M0449, 33F26A1659, 33F26B0196; ASK-42703-PHUMC1/10801902193275/33F25E0009, 33F25G0174, 33F25G0682, 33F25L0138, 33F26A0234; ASK-42703-PMSG1/10801902193275/33F25F0363; ASK-42703-POSU3/10801902193275, 10801902222579/33F25D0758, 33F25E0563, 33F25L0109, 33F26A1436, 33F26B0782; ASK-42703-PSAU1/10801902193275, 10801902159486/33F25A0258, 33F25C0300, 33F25D0543, 33F25J0108, 33F25J0273, 33F25M0093, 33F26B0758; ASK-42703-RHR1/10801902193275, 10801902163643/33F25E0311, 33F25G0262, 33F25H0425, 33F25L0060, 33F26A0238, 33F26C0483; ASK-42802-DU1/10801902161007, 10801902193275/33F24C0924, 33F24F0870, 33F24L0870, 33F25D0356, 33F25E0566, 33F25F0191, 33F25J0285, 33F26B0423; ASK-42802-PHF4/10801902200485, 10801902193275/33F24F0759, 33F25B0357, 33F25B0478, 33F25E0568, 33F25F0079, 33F25G0176, 33F25J0392, 33F25M0059, 33F26A1528, 33F26B0190, 33F26B0793; ASK-42802-PHHN1/10801902193275/33F25E0004, 33F25G0265, 33F25K0045, 33F25M0065; ASK-42802-POSU3/10801902193275, 10801902222586/33F25D0759, 33F25E0569, 33F25F0193, 33F25G0186, 33F25J0393, 33F26A1548, 33F26B0859; ASK-42802-PUCD1/10801902193275/33F25E0313, 33F25E1206; ASK-42802-PWHC1/10801902193275, 10801902134858/33F25B0498, 33F25E0680, 33F25F0195, 33F25J0160, 33F26B0418, 33F26C0164; ASK-42802-UHC/10801902193275, 10801902159745/33F25C0306, 33F25E0605, 33F25J0289, 33F26B0200; ASK-42854-MCY1/10801902193275, 10801902220995/33F24H0126, 33F24J0099, 33F25B0479, 33F25E0570, 33F25F0196, 33F25J0396, 33F26B0779; ASK-45703-BCH/10801902193275, 10801902222784/33F25F0004, 33F25F0117, 33F25G0184, 33F25G0185, 33F25H0508, 33F26A1381, 33F26B0876; ASK-45703-EMC/10801902160468, 10801902193275/33F24D0579, 33F24L0911, 33F25D0411, 33F25G0406, 33F25M0181, 33F26C0225; ASK-45703-MHMC1/10801902193275, 10801902213850/33F25B0580, 33F25D0366, 33F25E0574, 33F25G0224, 33F25H0463, 33F25J0231, 33F26B0129; ASK-45703-NWM/10801902193275/33F25F0006, 33F25F0105, 33F25M0009, 33F26A1463; ASK-45703-PCOR/10801902193275/33F24L0088, 33F25C0736, 33F25H0755; ASK-45703-PIMH/10801902193275/33F25B0588; ASK-45703-PK/10801902193275/33F25A0271, 33F25E0623; ASK-45703-PLGH2/10801902144536, 10801902193275/33F24D0901, 33F24F0995, 33F24L0213, 33F24L0964, 33F25C0315; ASK-45703-PMM4/10801902193275/33F25A0272; ASK-45703-PMM5/10801902193275, 10801902221947/33F25E0505, 33F25E0624, 33F25G0192, 33F25L0105, 33F25L0269, 33F26A1368, 33F26B0207, 33F26C0153; ASK-45703-POSU3/10801902193275, 10801902222593/33F25D0760, 33F25E0576, 33F25E0686, 33F25M0097, 33F26A1346, 33F26B0148, ASK-45703-PPHP1/10801902193275/33F24K0067, 33F25C0584, 33F25G0555, 33F26A0240; ASK-45703-PSAM/10801902116373, 10801902193275/33F24E0560, 33F24G0518, 33F24J0638, 33F25C0818, 33F25G0144, 33F25J0931, 33F26B0509; ASK-45703-PUCD1/10801902193275, 10801902221640/33F25D0237, 33F25D0607, 33F25H0653, 33F25K0159, 33F25M0228, 33F26A1499, 33F26B0374; ASK-45703-PUNCC2/10801902164268, 10801902193275/33F24D0696, 33F24F0690, 33F24K0439, 33F25B0598,33F25D0373, 33F25E0690, 33F25F0147, 33F25H0204, 33F25H0631, 33F25J0233, 33F26B0415; ASK-45854-PAMC1/10801902193275/33F25C0363, 33F25H0519, 33F25K0162, 33F26A0524; ASK-45854-PLGH1/10801902193275/33F24L0191, 33F25B0361, 33F25E0309, 33F25H0775, 33F26A0247; CDC-45802-XPN1A/10801902193275/33F25A0290, 33F25B0632, 33F25E0757, 33F25J0255, 33F26A1565; CDC-42703-XPN1A/10801902193275, 10801902162066/33F25F0069, 33F25F0332, 33F25H0879, 33F25H0881, 33F25J0224, 33F25J0693, 33F25J0697, 33F25J0717, 33F25J0721, 33F25L0014, 33F25L0250, 33F25M0019, 33F25M0028,33F26A0312, 33F26A0338, 33F26B0624, 33F26C0066, 33F26C0074, 33F26C0087, 33F26C0101, 36F25A0010, 36F25B0035, 36F25B0038, 36F25B0069, 36F25E0017, 36F25G0013, 36F25H0001, 36F25H0002, 36F25H0026, 36F25J0003; CDC-45703-PB1A/10801902117202, 10801902193275/33F24C1072, 33F24E0626, 33F24F0945, 33F25E0754, 33F25G0581, 33F25H0435, 33F25J0118, 33F25J0328; CDC-45854-P1A/30801902117275/33F24D0700, 33F24F0086, 33F24F0794, 33F25C0210, 33F25D0571, 33F25E0705, 33F25G0276, 33F25H0444, 33F25J0121, 33F25J0184, 33F25K0191, 33F26A1558, 33F26B0886;

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.

Firm notified the public via

Letter

FDA event ID

98793

Recall initiated

April 21, 2026

FDA classified

June 12, 2026

FDA report date

June 24, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 3:00 AM UTC.

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