Arrow International NextStep hemodialysis catheters recalled for introducer sheath splitting failure risk
Arrow NextStep hemodialysis catheters recalled for sheath introducer failure
A supplier defect in the 16F dual-valved splittable sheath introducer used in certain Arrow NextStep hemodialysis catheter kits may prevent the sheath from splitting as designed. This can cause difficulty during catheter placement, leading to prolonged procedures and potential complications including bleeding, tissue injury, or vessel wall damage.
- If you have one of the affected catheter kits, contact your healthcare provider or hospital before using it.
- Check the product reference number (REF) and lot number on your catheter packaging against the recall list.
- Do not use the affected catheters; return them to your supplier or facility for proper handling.
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2159-2026More ARROW INTERNATIONAL, LLC recalls
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