ARROW INTERNATIONAL, LLC — Description/REF: DRAINAGE KIT/AK-01600, DRAINAGE KIT/AK-01601, DRAINAGE KIT/ASK-01601-MM, THORACENTESIS KIT/AK-01000-T, THORACENTESIS KIT/AK-01000, THORACENTESIS KIT/ASK-010
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- April 21, 2026
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.
What's affected?
- Product
- Description/REF: DRAINAGE KIT/AK-01600, DRAINAGE KIT/AK-01601, DRAINAGE KIT/ASK-01601-MM, THORACENTESIS KIT/AK-01000-T, THORACENTESIS KIT/AK-01000, THORACENTESIS KIT/ASK-01000-CHP, DRAINAGE KIT/ASK-01000-NW, THORACENTESIS KIT/ASK-01000-UPMS, PNEUMOTHORAX KIT/AK-01500, PNEUMOTHORAX KIT (NO HEIMLICH VALVE)/ASK-01500, PNEUMOTHORAX KIT/ASK-01500-JCM
- Lot code
- (Batch):
Additional details
REF(Material)/UDI-DI/Lot(Batch): AK-01600/50801902120156, 10801902193275, 50801902120156, 60801902120160/33F24A0376, 33F24A1008, 33F24C0091, 33F24D0067, 33F24E0321, 33F24G0322, 33F24L0062, 33F24L0811, 33F24M0267, 33F25C0101, 33F25C0988, 33F25E0035, 33F25H0010, 33F25J0819, 33F26B0492, 33F24A0044; AK-01601/60801902120160, 10801902193275, 10801902190915/33F24A0783, 33F24A1070, 33F24C0092, 33F24E0322, 33F24G0323, 33F24J0273, 33F24L0651, 33F25C0102, 33F25C0916, 33F25E0036, 33F25G0078, 33F25J0460, 33F25L0371, 33F24B0427; ASK-01601-MM/10801902125726, 10801902193275, 10801902125726, 10801902205909/33F24F0656, 33F24K0319, 33F24M0166, 33F25A0163, 33F25E0587, 33F25G0164, 33F25L0116, 33F26A1377, 33F26C0174, 33F24F0213; AK-01000-T/10801902145120, 10801902193275, 10801902194029/33F24C0090, 33F24D0066, 33F24E0319, 33F24G0320, 33F24K0085, 33F24L0792, 33F25C0872, 33F25E0033, 33F25J0459, 33F25L0367, 33F24A0015; AK-01000/10801902197952, 10801902193275, 10801902197952, 10801902145120/33F24A0017, 33F24A0018, 33F24A0348, 33F24A0349, 33F24A0350, 33F24A0351, 33F24A1005, 33F24A1006, 33F24D0005, 33F24D0006, 33F24D0007, 33F24D0008, 33F24D0009, 33F24D0010, 33F24D0011, 33F24D0012, 33F24E0032, 33F24E0033, 33F24E0034, 33F24E0035, 33F24E0036, 33F24E0037, 33F24E0038, 33F24E0041, 33F24E0042, 33F24E0167, 33F24E0168, 33F24E0169, 33F24E0170, 33F24E0171, 33F24G0319, 33F24G0567, 33F24G0568, 33F24J0487, 33F24J0673, 33F24K0084, 33F24K0308, 33F24K0312, 33F24L0626, 33F24L0726, 33F24L0782, 33F24L0787, 33F25A0454, 33F25A0611, 33F25A0612, 33F25C0100,33F25C0211,33F25C0905,33F25C0954, 33F25E0032,33F25E0286, 33F25E0287, 33F25E0908, 33F25E1063, 33F25E1064, 33F25G0076, 33F25G0157, 33F25H0008, 33F25H0188, 33F25H0189, 33F25H0190, 33F25H0191, 33F25H0192, 33F25J0458, 33F25J0740, 33F25J0741, 33F25J0788, 33F25J0799, 33F25J0800, 33F25K0250, 33F25K0251, 33F25K0360, 33F25K0361, 33F25K0362, 33F25K0363, 33F25L0019, 33F25L0020, 33F25L0100, 33F25L0101, 33F25L0268, 33F25L0485, 33F25L0487, 33F25M0831, 33F25M0860, 33F26A0217, 33F26A0218, 33F26A0693, 33F26A0988, 33F26B0505, 33F26B0506, 33F26C0574, 33F24A0794; ASK-01000-CHP/10801902193275, 30801902120190, 10801902203134/33F24G0228, 33F24J0192, 33F24K0020, 33F24L0021, 33F24L0523, 33F24M0063, 33F25B0010, 33F25B0061, 33F25B0132, 33F25C0405, 33F25D0198, 33F25H0277, 33F25H0810, 33F25J0995, 33F26A1273, 33F26B0695, 33F24E0388; ASK-01000-NW/10801902193275, 10801902114867/33F24G0390, 33F24K0153, 33F25B0693, 33F25C0873, 33F25H0051, 33F25J0854, 33F25M0921, 33F24A0645; ASK-01000-UPMS/10801902114867, 10801902193275/33F24B0805, 33F24C0930, 33F24D0683, 33F24H0186, 33F24L0214, 33F24L0912, 33F25B0542, 33F25D0325, 33F25D0527, 33F25F0156,33F25J0099, 33F25J0196, 33F25L0270, 33F26A1392, 33F24G0276; AK-01500/10801902194029, 10801902193275, 50801902120156/33F24E0044, 33F24E0172, 33F24E0173, 33F24G0321, 33F24G0569, 33F24J0488, 33F24K0086, 33F24K0573, 33F24L0724, 33F25A0455, 33F25C0722, 33F25D0126, 33F25E0034, 33F25E0909, 33F25G0077, 33F25G0549, 33F25H0009, 33F25H0720, 33F25J0818, 33F25L0384, 33F26B0535, 33F26C0263, 33R24E0044, 33F23K0711; ASK-01500/10801902156232, 10801902193275, 30801902120206/33F24A0777, 33F24C0130, 33F24E0391, 33F24G0392, 33F24J0542, 33F24L0765, 33F25C0127, 33F25C0735, 33F25E0105, 33F25H0053, 33F25J0495, 33F25L0335, 33F24A1274; ASK-01500-JCM/30801902120206, 10801902193275, 10801902125726
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: 444,943.
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