FDA Device recall Z-2156-2026
Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I
- FDA Device
- Class I
- ongoing
- Published 2026-05-20
On 2026-05-20 the FDA classified a Class I recall of Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I by Arrow International, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2156-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2026-04-10 |
| Published | 2026-05-20 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Arrow International |
| Distribution | US |
Product
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.
Identifiers
| code_info | REF/UDI-DI/Lot: CS-15242-I/ 30801902195280/33F23G0536; CS-15282-I/30801902195532/33F23C0877, 33F24A0281, 33F24H0041; CS-15322-I/30801902197451/33F23G0545 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2156-2026%22
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