fda_recall · device_recall · critical
ARROW INTERNATIONAL, LLC — Class I recall: NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SF…
- Event date
- 2026-05-20 00:00:00Z
- Observed
- 2026-07-09 22:52:30Z
- Source ID
- Z-2159-2026
- Payload hash
- 927cdb9187a64ec7e9997169…
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 inju… Status: Ongoing.
Entities
Informational only. Not legal, financial, or medical advice.