FDA Recall Open, Classified

NextStep Antegrade Chronic Hemodialysis Catheter, REF: 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-Introducer, REF: CS-15192-SFXM, CS-15232-SFXM; NextStep Retrograde Hemodialysis Catheter, REF: 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-Introducer, REF: CS-15192-XM, CS-15232-XM, CS-15272-XM, CS-15312-XM

Recall: Z-2159-2026 · Initiated April 10, 2026

Recall

Recall Number: Z-2159-2026
Event Number: 98745
Firm: ARROW INTERNATIONAL, LLC
FEI Number: 3013162291
Product Code: MSD
Status: Open, Classified
Root Cause: Nonconforming Material/Component
Initiated: April 10, 2026
Posted: May 13, 2026
Address: 3015 Carrington Mill Blvd, Morrisville, NC, 27560-5437

Description

Reason

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.

Action

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 ([email protected]), phone (1-866-396-2111), or FAX (1-855-419-8507).

Distribution

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

Quantity

19,687