FDAFDA recall Z-2377-2026 · Jun 24, 2026

ARROW INTERNATIONAL, LLC: Description/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 20 GA X 1-3 recall

Recall found

Product

Description/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-X1ASP ACCESS TRAY/ASK-04001-MS RA CATH KIT: 20 GA X 8 CM/ASK-00820-UM1 VESSEL CATH KIT: 20GA X 5IN/AK-04550-S CVC KIT: 1-LUMEN 5 FR X 20 CM/AK-04301-SP CVC KIT: 16 GA X 6IN (16 CM)/AK-04306-SP CVC KIT: 16GA X 6 IN/AK-04800-S CVC KIT: 2-LUMEN 4 FR X 5 CM/AK-12402 CVC KIT: 3-LUMEN 7 FR X 16 CM/AK-12703-CDC CVC KIT: 2L 4 FR X 13 CM/AK-14402 CVC KIT: 2-LUMEN 5 FR X 13 CM/AK-14502 CVC KIT: 3-LUMEN 5.5 FR X 30 CM/AK-14553 CVC KIT: 3-LUMEN 7 FR X 30 CM/AK-14703-SP CVC KIT: 2-LUMEN 4 FR X 8 CM/AK-15402 CVC KIT: 3-LUMEN 5.5 FR X 8 CM/AK-15553 CVC KIT: 2-LUMEN 4 FR X 30 CM/AK-16402 CVC KIT: 3-LUMEN 5.5 FR X 13 CM/AK-16553 CVC KIT: 5 FR X 20 CM/ASK-04301-HH2 CVC KIT 3L: 7 FR X 6 IN (16 CM)/ASK-12703-MGH3

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.

What to do

FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.

Recall details

FDA classification: Class I: FDA's most serious class, where use of or exposure to the product may cause serious health problems or death.
Status: Ongoing
Codes, lots and dates: REF(Material)/UDI-DI/Lot(Batch): ASK-04510-MM6/10801902193275, 10801902221909/33F25E0590, 33F25G0196, 33F25M0005, 33F25M0149, 33F26A0302, 33F26C0723, 33F24K0212; NA-04020-X1ASP/10801902193275/33F25J0575, 33F25J0756, 33F26B0065, 33F26B0027; ASK-04001-MS/10801902193275/33F24K0706, 33F25F0375, 33F25F0005; ASK-00820-UM1/10801902193275/33F24G0150; AK-04550-S/10801902196719, 10801902193275, 60801902121709/33F24A0029, 33F24A0355, 33F24A1014, 33F24A1619, 33F24B0112, 33F24C0548, 33F24D0017, 33F24E0174, 33F24G0328, 33F24G0576, 33F24J0276, 33F24J0494, 33F24K0092, 33F24L0720, 33F25A0458, 33F25C0950 33F25E0041, 33F25E0911, 33F25G0080, 33F25H0013, 33F25J0820, 33F25L0402, 33F26B0550, 33F26C0267, 33F23M0175; AK-04301-SP/10801902121650, 10801902193275, 10801902121674/33F24A1010, 33F24C0093, 33F24D0068, 33F24E0325, 33F24G0325, 33F24J0274, 33F24K0090, 33F24L0809, 33F25C0757, 33F25E0038, 33F25G0760, 33F25H0721, 33F25J0462, 33F25L0239, 33F25M0888, 33F24A0146; AK-04306-SP/10801902121674, 10801902193275, 10801902192230/33F24A0846, 33F24B0174, 33F24C0094, 33F24E0327, 33F24E0329, 33F24J0275, 33F24J0492, 33F24L0717, 33F25B0249, 33F25C0783, 33F25E0039, 33F25J0463, 33F25L0054, 33F25L0345, 33F26B0684, 33F23J0175; AK-04800-S/60801902121709, 10801902193275, 10801902209501/33F24B0437, 33F24C0735, 33F24E0708, 33F24G0120, 33F24G0647, 33F24H0415, 33F24J0448, 33F24L0037, 33F24M0128, 33F25A0396, 33F25B0111, 33F25D0028, 33F25G0509, 33F25H0326, 33F25J0997, 33F26C0274, 33F24C0013; AK-12402/10801902168471, 10801902193275, 10801902168488/33F24E0342, 33F24F0325, 33F24G0347, 33F24J0512, 33F24K0113, 33F24L0750, 33F25C0109, 33F25C0964, 33F25E0063, 33F25E0926, 33F25J0474, 33F24A0408; AK-12703-CDC/10801902168488, 10801902193275, 10801902168495/33F24A1020, 33F24B0187, 33F24C0104, 33F24D0078, 33F24G0348, 33F24J0513, 33F24K0114, 33F24L0596, 33F25C0110, 33F25C0759, 33F25J0834, 33F25M0948, 33F24A0401; AK-14402/10801902168495, 10801902193275, 10801902168495, 10801902168518/33F24E0177, 33F24E0343, 33F24F0328, 33F24G0349, 33F24J0514, 33F24K0115, 33F25B0369, 33F25C0875, 33F25E0064, 33F25E0928, 33F25H0029, 33F25J0475, 33F26B0564, 33F24A0813; AK-14502/10801902168518, 10801902193275, 30801902122040/33F24E0344, 33F24G0350, 33F24K0116, 33F24L0656, 33F25C0878, 33F25E0065, 33F25G0089, 33F25J0476, 33F26B0568, 33F24A0849; AK-14553/30801902122040, 10801902193275, 10801902122077/33F24B0190, 33F24C0107, 33F24E0345, 33F24E0346, 33F24F0332, 33F24G0351, 33F24K0117, 33F24L0689, 33F25C0112, 33F25C0848, 33F25G0090, 33F25J0835, 33F24B0191; AK-14703-SP/10801902122077, 10801902193275, 10801902197136/33F24E0347, 33F24G0352, 33F24J0516, 33F24K0118, 33F24L0737, 33F25A0476, 33F25C0887, 33F25E0067, 33F25E0929, 33F25J0477, 33F25L0399, 33F25M0905, 33F24D0079; AK-15402/10801902168532, 10801902193275, 10801902168532, 10801902168549/33F24B0194, 33F24E0350, 33F24G0354, 33F24H0034, 33F24J0518, 33F24K0120, 33F24L0751, 33F25A0479, 33F25C0799, 33F25E0069, 33F25E0932, 33F25H0723, 33F25J0836, 33F25L0348, 33F26C0317, 33F24A1268; AK-15553/10801902168549, 10801902193275, 10801902168549, 10801902168563/33F24E0714, 33F24G0226, 33F24G0687, 33F24H0249, 33F24J0353, 33F25B0332, 33F25D0195, 33F25H0796, 33F25J0081, 33F26B0287, 33F24A1269; AK-16402/10801902168563, 10801902193275, 10801902168563, 10801902168570/33F24C0738, 33F24E0715, 33F24H0065, 33F24H0416, 33F24J0212, 33F24J0426, 33F25A0046, 33F25C0087, 33F25C0604, 33F25G0458, 33F25J0082, 33F26A1658, 33F26B0069, 33F26C0446, 33F24A0796; AK-16553/10801902168570, 10801902193275, 30801902122248/33F24E0178, 33F24E0351, 33F24G0355, 33F24J0519, 33F24K0121, 33F24L0790, 33F25C0980, 33F25E0070, 33F25J0478, 33F24C0025; ASK-04301-HH2/10801902193275, 20801902114987/33F25H0640, 33F25K0070, 33F25K0090, 33F24D0733; ASK-12703-MGH3/10801902193275, 10801902115260/33F25D0263, 33F24F0838
Quantity: 126,530
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.
Recalling firm: ARROW INTERNATIONAL, LLC, Morrisville, NC
Voluntary or mandated: Voluntary: Firm initiated
Recall started: 2026-04-21

Source: openFDA enforcement record Z-2377-2026 · search recall number Z-2377-2026 in FDA's Enforcement Report.

Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.