- Recalling firm
- ARROW INTERNATIONAL, LLC
- Reason for recall
- 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.
- Affected products (lot / model / serial)
- REF/UDI-DI/Lots: AC-15192-SFX/30801902197758/AC-15192-SFX; AC-15232-SFX/00801902095909/33F23H1018; CS-15192-SFX/30801902195297/33F23E0575, 33F23G0530, 33F23K0187, 33F23K1104, 33F23L0929, 33F24A0275, 33F24C0068, 33F24D1012, 33F25C0020, 33F25E1083, 33F25G0636, 33F25H0292, 33F25H0790, 33F25L0038; CS-15232-SFX/30801902195549/33F23E0576, 33F23G0534, 33F23L0936, 33F24A0279, 33F24C0067, 33F24D1006, 33F24E0684, 33F24H0258, 33F24J0033, 33F24J0085, 33F24J0342, 33F24L0056, 33F24M0231, 33F25A0405, 33F25C0036, 33F25C0664, 33F25D0739, 33F25E0433, 33F25G0716, 33F25H0248; CS-15272-SFX/10801902195217/33F23B0321, 33F23D0859, 33F23H0500, 33F23K0177, 33F23L0943, 33F24A0280, 33F24C0083, 33F24H0042, 33F24H0260, 33F24J0022, 33F24J0038, 33F24J0088, 33F24L0177, 33F25C0028, 33F25E1090, 33F25F0301, 33F25F0514; CS-15312-SFX/30801902197529/33F23G0541, 33F23H0984, 33F23L0951, 33F24A0283; CS-15422-SFX/30801902195327/33F23K0179, 33F23L0956, 33F24A0290, 33F24E0814; CS-15502-SFX/30801902195563/33F23L0959, 33F24A0286, 33F24J0060; CS-15192-SFXM/10801902127157/33F25C0015, 33F25E1084; CS-15232-SFXM/10801902127232/33F25C0671; AC-15192-X/ 00801902095879/33F23F0744, 33F24E0784, 33F25D0685; AC-15232-X/00801902095916/33F23H1013, 33F24J0068, 33F25C0675, 33F25J0589; AC-15272-X/00801902095954/33F23H1023; CS-15192-X/30801902195303/33F23C0886, 33F23E0564, 33F23G0263, 33F23G0533, 33F23K0712, 33F23L0935, 33F24E0187, 33F24E0793, 33F24G0171, 33F24J0017, 33F24J0041, 33F25D0701, 33F25E0476, 33F25F0486, 33F25H0783, 33F25H0857; CS-15232-X/30801902195556/33F23C0862, 33F23E0566, 33F23F0722, 33F23K0171, 33F23L0940, 33F24A0916, 33F24C0061, 33F24D1037, 33F24E0800, 33F24J0043, 33F24L0176, 33F25A0028, 33F25C0029, 33F25C0644, 33F25D0096, 33F25E0352, 33F25F0300, 33F25F0513, 33F25E0477, 33F25J0745; CS-15272-X/10801902195224/33F23C0887, 33F23F0731, 33F23H0983, 33F23K0190, 33F23L0947, 33F24E0807, 33F24F0124, 33F24J0018, 33F24J0050, 33F24L0054, 33F24L0063, 33F24M0006, 33F25C0684, 33F25E0342, 33F25F0276, 33F25J0641; CS-15312-X/30801902195310/33F23C0863, 33F23D0858, 33F23G0544; CS-15192-XM/10801902127225/33F25D0711; CS-15232-XM/10801902127300/33F25E0435; CS-15272-XM/10801902127409/33F25C0680, 33F25K0272; CS-15312-XM/10801902127508/33F25E0442
- Units affected
- 19,687
- Distribution pattern
- Worldwide distribution: US nationwide and countries of: AE, AL, AR, AT, AU, BE, BG, BS, BR, BW, CA, CH, CL, CN, CO, CZ, DE, EC, EE, ES, FR, GB, GR, GT, HU, ID, IE, IN, IT, JP, KW, KZ, LB, LT, LU, MN, MZ, NA, NL, NO, NP, NZ, PA, PE, PF, PH, PL, PT, QA, RO, RS, RU, SA, SG, SL, SK, SZ, TH, TN, TR, TT, UA, VN, ZA, ZM, and ZW
- Firm location
- Morrisville, NC, United States
- Recall type
- Voluntary: Firm initiated
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2159-2026
- Recall initiated
- April 10, 2026
- FDA classification date
- May 13, 2026
- FDA report date
- May 20, 2026
- FDA event ID
- 98745
- Last updated on HTM Vibe
- July 24, 2026