FDA DeviceClass INotable
FDA Recall: NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SFX, CS-15192-SFX, CS-
Description
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.
Hazard
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.
Remedy
19,687
Related Recalls
2026-05-20 · FDA_DEVICE
FDA Recall: Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I
ARROW INTERNATIONAL, LLC
2026-05-20 · FDA_DEVICE
FDA Recall: Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-15322-VSP, CS-15362-VSP, C
ARROW INTERNATIONAL, LLC
2026-05-20 · FDA_DEVICE
FDA Recall: Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-VFI, ACS-15232-VFI, A
ARROW INTERNATIONAL, LLC
2026-04-29 · FDA_DEVICE
FDA Recall: Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)2512
ARROW INTERNATIONAL, LLC