Arrow Edge Hemodialysis Catheterization Kit recalled for splittable sheath introducer malfunction
Arrow Edge hemodialysis kit recalled for sheath introducer defect
Arrow International included a defective 16F dual-valved splittable sheath introducer in certain hemodialysis catheterization kits. The sheath introducer may not split properly during removal, potentially causing withdrawal resistance, prolonged procedure time, pain, bleeding, and tissue or vessel wall injury.
- Check if your facility received affected kits with reference numbers CS-15242-I, CS-15282-I, or CS-15322-I
- Do not use affected kits; contact Arrow International or the FDA for return and replacement instructions
- Review lot numbers 33F23G0536, 33F23C0877, 33F24A0281, 33F24H0041, and 33F23G0545 against your inventory
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-2156-2026More ARROW INTERNATIONAL, LLC recalls
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