FDAFDA · Food and drugs·Recall number Z-2376-2026

Description/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH; CVC KIT: 3-LUMEN 12 FR X 16 CM/AK-12123-F; CVC KIT: 3-LUMEN 12 FR X 20 CM/AK-15123-F; 3L CVC KIT: 7 FR X 16 CM/ASK-12703-PMAH; 3L PI CVC KIT: 7 FR X 16 CM/ASK-12703-PNM; 3L CVC KIT: 7 FR X 16 CM/ASK-12703-PUMH; MULTILUMEN PI CVC KIT: 3L 7 FR X 8 IN/ASK-15703-PRH; MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/CDC-15703-P1A; PI CVC KIT: 3-L 7 FR X 6IN (16 CM)/NA-12703-PCDC; PI CVC KIT: 3-L 7 FR X 8IN (20 CM)/NA-15703-PCDC; CVC KIT: 3-LUMEN 5.5 FR X 8 CM/AK-25553; 2-L CVC KIT: 4 FR X 5 CM/CDC-22402-X1A; 2-L CVC KIT: 5 FR X 5 CM/CDC-22502-X1A; 2-L CVC KIT: 4 FR X 8 CM/CDC-25402-X1A; 2-L CVC KIT: 5 FR X 8 CM/CDC-25502-X1A; 3-L CVC KIT: 5.5 FR X 8 CM/CDC-25553-X1A; 3-L CVC KIT: 5.5 FR X 13 CM/CDC-26553-X1A; CVC KIT 3L: 12 FR X 16 CM AGB/AK-22123-CDC; CVC KIT: 3-LUMEN 12 FR X 16 CM/AK-22123-F; CVC KIT: 2-LUMEN 4 FR X 5 CM/AK-22402; CVC KIT: 2-LUMEN 5 FR X 5 CM/AK-22502; CVC KIT: 16 GA X 8IN/AK-24301-SK; CVC KIT: 2-LUMEN 4 FR X 13 CM/AK-24402; CVC KIT: 3-LUMEN 7 FR X 30 CM/AK-24703-ASK; CVC KIT 3L: 12FR X 20 CM AGB/AK-25123-CDC; CVC KIT: 3-LUMEN 12 FR X 20 CM/AK-25123-F; CVC KIT: 2-LUMEN 4 FR X 8 CM/AK-25402; CVC KIT: 2-LUMEN 5 FR X 8 CM/AK-25502; CVC KIT: 3-LUMEN 5.5 FR X 13 CM/AK-26553; LBCVC KIT: 3L 12 FR X 16 CM AGB/CDC-22123-1A; LBCVC KIT: 3L 12 FR X 16 CM AGB/CDC-22123-X1A; CVC KIT: 16 GA X 20 CM/CDC-24301-1A; PI CVC KIT: 2L 7 FR X 16 CM AGB/AK-22702-P1A; PI CVC KIT: 2L 7 FR X 16 CM AGB/CDC-22702-XP1A; CVC KIT: 3L 7 FR X 20 CM/ASK-45703-CPR; MULTILUMEN PI CVC KIT: 3L 7 FR X 16 CM/ASK-42703-AKP1A; MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 6IN/ASK-42703-KH; PI CVC KIT: 3L 7FR X 16CM AGB+/ASK-42703-MGH1; MULTI LUMEN PI CVC KIT: 3L 7 FR X 6IN/ASK-42703-PCCH2; PI CVC KIT: 3LUMEN 7 FR X 6IN (16 CM)/ASK-42703-PFS1; PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNO2; MULTI LUMEN PI CVC KIT: 3L 7 FR/ASK-42703-PSCH1; MULTILUMEN PI CVC KIT: 2L 8 FR X 16 CM/ASK-42802-AKP1A; CVC KIT: 2L 8 FR X 16CM/ASK-42802-LMDTG1; PI CVC KIT: 2L 8 FR X 6 IN (16 CM) AGB+/ASK-42802-PUCI1; PI CVC KIT: 2L 8 FR X 16 CM AGB+/ASK-42802-PUMH; PI CVC KIT: 2L 8 FR X 16 CM AGB+/ASK-42802-UMM; PI CVC KIT: 4-L 8.5 FR X 6 IN/ASK-42854-AKP1A; PI CVC KIT: 4L 8.5FR X 16CM AGB+/ASK-42854-MGH; MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-AKP1A; PI CVC KIT: 3L 7 FR X 20CM AGB+/ASK-45703-MGH; MULTI LUMEN PI CVC KIT: 3L 7 FR X 8 IN/ASK-45703-PCCH2; MULTI LUMEN PI CVC KIT: 3L 7 FR X 8 IN/ASK-45703-PECL1; PI CVC KIT: 3 LUMEN 7 FR X 8 IN (20 CM)/ASK-45703-PFS1; PI CVC KIT: 3L 7 FR X 8 IN (20 CM) AGB+/ASK-45703-PHM1; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PHU; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PMSG1; MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PNCB; MULTILUMEN CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PPCM; PI CVC KIT: 3-LUMEN 7 FR X 8 IN (20 CM)/ASK-45703-PRH; MULTILUMEN PI CVC KIT: 3L 7 FR X 8 IN/ASK-45703-PSJ2; PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PSVM; MULTI LUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-PUHS; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PUKL; PI CVC KIT: 3L 7FR X 20CM AGB+/ASK-45703-PUMF1; PI CVC KIT: 3L 7 FR X 8 IN (20 CM)/ASK-45703-PUR1; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-RHR1; MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM/ASK-45703-WA; MULTI LUMEN PI CVC KIT: 2L 8 FR X 8 IN/ASK-45802-AKP1A; PI CVC KIT: 4L 8.5 FR X 20 CM/ASK-45854-AKP1A; PI CVC KIT: 4L 8.5FR X 20CM AGB+/ASK-45854-MGH; PI CVC KIT: 4L 8.5 FR X 8IN/ASK-45854-PCCH2; CVC KIT: 4L 8.5 FR X 20 CM AGB/ASK-45854-PNM; MULTI LUMEN CVC KIT: 4L 8.5 FR X 8 IN/ASK-45854-PPCM; PI CVC KIT: 4L 8.5 FR X 20 CM AGB+/ASK-45854-PUCH2; MULTILUMEN PI CVC KIT: 2L 7 FR X 20 CM/ASK-46702-PWBH1; MULTILUMEN CVC KIT: 2L 8 FR X 16 CM/CDC-42802-P1A; PI CVC KIT: 3-L 7 FR X 20 CM AGB/CDC-45703-PA1A; CVC KIT: 2L 8 FR X 6IN (16 CM)/ASK-42802-ECL4; PI CVC KIT: 3-L 7 FR X 16 CM AGB+/AK-42703-P1A; PI CVC KIT: 2-L 8 FR X 16 CM AGB+/AK-42802-P1A; PI CVC KIT: 4-L 8.5 FR X 16 CM AGB+/AK-42854-P1A; PI CVC KIT: 3-L 7 FR X 20 CM AGB+/AK-45703-P1A; PI CVC KIT: 2-L 8 FR X 20 CM AGB

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): ASK-42802-PLH/10801902193275, 10801902133110, 10801902212013/33F25L0140 33F26B0222, 33F24F0799; AK-12123-F/10801902168464, 10801902193275, 10801902186338/33F24B0185, 33F24C0102, 33F24D0077, 33F24F0323, 33F24G0346, 33F24K0112, 33F25C0929, 33F25E0062, 33F25H0028, 33F25J0833, 33F24G0129; AK-15123-F/10801902168525, 10801902193275, 10801902186499/33F24C0108, 33F24E0349, 33F24G0353, 33F24L0650, 33F25A0478, 33F25C0779, 33F25E0068, 33F25M0946, 33F24E0713; ASK-12703-PMAH/10801902193275/33F24J0116; ASK-12703-PNM/10801902193275, 10801902214338/33F24L0197, 33F24D0725; ASK-12703-PUMH/10801902193275, 10801902164602/33F25L0030, 33F24F0914; ASK-15703-PRH/10801902193275, 10801902133226/33F25C0271, 33F25F0168, 33F25J0101, 33F25J0368, 33F26A1500, 33F24C0858; CDC-15703-P1A/10801902116793, 10801902193275/33F24D0980, 33F24E0236, 33F24E0832, 33F24G0252, 33F24H0074, 33F24H0401, 33F24H0457, 33F24J0195, 33F24K0024, 33F24M0016, 33F24M0017, 33F24M0064, 33F25B0116, 33F25C0577, 33F25D0719, 33F25G0427, 33F25G0441, 33F25G0663, 33F25H0361, 33F25J1039, 33F25M0495, 33F25M0512, 33F25B0670; NA-12703-PCDC/10801902193275, 10801902119978, 10801902119985/33F24G0555, 33F24K0298, 33F25A0602, 33F25E1055, 33F25H0180, 33F25J0942, 33F25L0474, 33F26B0598, 33F24D0414; NA-15703-PCDC/10801902119985, 10801902193275, 10801902119985, 10801902210217/33F24F0191, 33F24G0556, 33F24J0336, 33F24K0572, 33F25A0157, 33F25C0200, 33F25C0833, 33F25E0275, 33F25H0181, 33F25H0762, 33F25J0943, 33F25L0456, 33F26B0587, 33F25A0603; AK-25553/10801902193275, 10801902167801/33F24H0250, 33F24M0062, 33F25A0382, 33F25B0310, 33F25C0069, 33F25C0506, 33F26C0405, 33F24G0377; CDC-22402-X1A/)10801902193275/33F25K0177, 33F26B0893, 33F25E1192; CDC-22502-X1A/10801902193275/33F25F0216, 33F25C0331; CDC-25402-X1A/10801902193275, 20801902116974/33F25A0287, 33F25D0505, 33F25E0824, 33F25H0569, 33F26A1470, 33F26B0216, 33F24L0486; CDC-25502-X1A/10801902193275/33F24L0980, 33F25D0506, 33F25E0698, 33F25G0315, 33F25J0429, 33F26A1472, 33F24L0832; CDC-25553-X1A/10801902193275, 10801902168129, 60801902123611/33F25E0890, 33F25E1191, 33F26A1384, 33F26B0708, 33F24F0084; CDC-26553-X1A/10801902193275, 10801902168136, 50801902117019/33F25E0749, 33F25E1190, 33F25J0432, 33F26B0807, 33F26C0210, 33F26D0063, 33F24D0807; AK-22123-CDC/10801902193275, 10801902167740/33F24K0127, 33F25A0483, 33F25E0076, 33F25E0938, 33F25H0032, 33F25J0480, 33F25K0398, 33F25M0960, 33F24E0358; AK-22123-F/10801902193275/33F24G0362, 33F24J0526, 33F24K0128, 33F24L0762, 33F25C0963, 33F25E0939, 33F25H0033, 33F24G0363; AK-22402/10801902193275, 10801902167764/33F24L0704, 33F25A0484, 33F25C0817, 33F25E0079, 33F25H0035, 33F25L0373, 33F25M0879, 33F24B0203; AK-22502/10801902193275, 10801902167764/33F24E0363, 33F24G0366, 33F24K0131, 33F24L0708, 33F25C0885, 33F25J0842, 33F24K0487; AK-24301-SK/10801902193275/33F24G0367, 33F24J0528, 33F24K0132, 33F24L0680, 33F25C0118, 33F25C0775, 33F25E0080, 33F25G0092, 33F25H0036, 33F25H0724, 33F25J0482, 33F25L0411, 33F25M0915, 33F24K0133; AK-24402/10801902193275/33F24L0059, 33F24L0727, 33F25C0119, 33F25C0976, 33F25E0081, 33F24K0134; AK-24703-ASK/10801902193275, 10801902118971, 60801902123178/33F24L0778, 33F25C0928, 33F25E0082, 33F25H0037, 33F25J0843, 33F26B0495, 33F24F0281; AK-25123-CDC/10801902193275/33F24K0136, 33F24L0730; AK-25123-F/10801902193275/33F25C0913, 33F25E0085, 33F25E0943, 33F25J0484, 33F26B0496, 33F24G0374; AK-25402/10801902193275, 10801902167795/33F24G0376, 33F24J0282, 33F24K0139, 33F24L0752, 33F25C0121, 33F25C0968, 33F25G0093, 33F25J0486, 33F25L0381, 33F26B0532, 33F24G0688; AK-25502/10801902193275, 10801902180381/33F24H0051, 33F24M0001, 33F25A0125, 33F25B0333, 33F25F0256, 33F25F0500, 33F25H0807, 33F25K0228, 33F25L0163, 33F26A0051, 33F26B0266, 33F24G0689; AK-26553/10801902193275, 20801902117506/33F24K0140, 33F24L0776, 33F25E0089, 33F25G0094, 33F25J0847, 33F25L0410, 33F25M0914, 33F24D0024; CDC-22123-1A/10801902168044, 10801902193275/33F24F0943, 33F24L0472, 33F25A0325
Risk classification: Class I
Area (FDA): device
Country: United States

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