NextStep Antegrade Hemodialysis Catheter with Arrow Simplicity Micro-Introducer, REF: CS-15192-SFXM, CS-15232-SFXM - 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits

Source: FDA | Recall date: 05/20/2026

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Affected product: NextStep Antegrade Hemodialysis Catheter with Arrow Simplicity Micro-Introducer, REF: CS-15192-SFXM, CS-15232-SFXM

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 inju

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 inju

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