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FDAApril 10, 2026device

Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

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UPCs

308019021952803080190219553230801902197451

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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