ARROW INTERNATIONAL, LLC recalls NextStep Antegrade Chronic Hemodialysis Catheter
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 product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
NextStep Antegrade Chronic Hemodialysis Catheter8 codes
- AC-15192-SFX
- AC-15232-SFX
- CS-15192-SFX
- CS-15232-SFX
- CS-15272-SFX
- CS-15312-SFX
- CS-15422-SFX
- CS-15502-SFX
NextStep Antegrade Hemodialysis Catheter with Arrow Simplicity Micro-Introducer2 codes
- CS-15192-SFXM
- CS-15232-SFXM
NextStep Retrograde Hemodialysis Catheter7 codes
- AC-15192-X
- AC-15232-X
- AC-15272-X
- CS-15192-X
- CS-15232-X
- CS-15272-X
- CS-15312-X
NextStep Retrograde Hemodialysis Catheter with Arrow Simplicity Micro-Introducer4 codes
- CS-15192-XM
- CS-15232-XM
- CS-15272-XM
- CS-15312-XM
Lot / code information
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
What the firm is doing
On 4/10/2026, recall notices were mailed to customers who were informed of the following Arrow International LLC is recalling product due to the Merit Medical Systems, Inc. recall of the Merit 16F Dual-Valved Splitable Sheath Introducer component, which is included in impacted Arrow Hemodialysis Kits & Sets. Customers were asked to do the following: 1) Users should cease use and distribution of affected product and immediately quarantine the affected product. 2) Complete and return the Acknowledgement Form, see link: https://fca.myteleflex.com/en/recall/000605 3) This notice should be passed on to all persons who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. In addition, distributors were asked to do the following: - Provide a copy of this field safety notice to all customers who have received impacted product. Each of your customers is then required to complete the Acknowledgement Form and return it to you as their distributor. Should you require further information or support concerning this issue, please contact Customer Service via email (Recalls@teleflex.com), phone (1-866-396-2111), or FAX (1-855-419-8507).
DistributionShow detailsHide
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
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2159-2026
- FDA 510(k) clearance · K111117The device's official FDA premarket clearance record
- FDA 510(k) clearance · K111900The device's official FDA premarket clearance record
- FDA device classification · MSDOfficial FDA classification for this device type
- CFR regulation · 21 CFR 876.5540The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find ARROW INTERNATIONAL, LLCSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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