[pending] Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I
Pending LLM rewrite. Source: FDA_DEVICE Z-2156-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I
- Manufacturer
- ARROW INTERNATIONAL, LLC
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- REF/UDI-DI/Lot: CS-15242-I/ 30801902195280/33F23G0536
- CS-15282-I/30801902195532/33F23C0877
- 33F24A0281
- 33F24H0041
- CS-15322-I/30801902197451/33F23G0545
Distribution
Distributed nationwide across the United States.