Arrow Edge Hemodialysis Catheterization Product recall (ARROW INTERNATIONAL, LLC)
Medical deviceClass IOngoing
Summary: ARROW INTERNATIONAL, LLC is recalling Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I. 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.
What is being recalled
Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I
Why
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.
How serious is it
Class I is the most serious level: FDA considers there is a reasonable probability that using or being exposed to this product will cause serious health problems or death.
Where it was sold
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 (states named: Alabama, Arkansas, California, Minnesota, Tennessee)
How to tell if yours is affected
REF/UDI-DI/Lot: CS-15242-I/ 30801902195280/33F23G0536; CS-15282-I/30801902195532/33F23C0877, 33F24A0281, 33F24H0041; CS-15322-I/30801902197451/33F23G0545
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2156-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class I |
| Status | Ongoing |
| Recall started | April 10, 2026 |
| Reported | May 20, 2026 |
| Company | ARROW INTERNATIONAL, LLC |
| Company location | Morrisville, NC, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 285 |
More recalls from ARROW INTERNATIONAL, LLC · all medical device recalls · recalls from April 2026