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Early Alert: Arrow International Removes Dialysis Catheter Kits Containing Merit Medical Splittable Sheath Introducers
The FDA is aware that Arrow International has initiated an urgent Medical Device Recall notification for kits that contain hemodialysis catheters affected by a previous recall of Merit Medical’s 16F Dual-Valved Splittable Sheath Introducers.
Merit Medical is recalling the Merit 16F Dual-Valved Splittable Sheath Introducer due to a design defect where the sheath introducer may not split as intended. This sheath introducer is used in several impacted Arrow Hemodialysis Kits and Sets. Failure of the sheath introducer to split as intended may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.
Merit Medical reported two serious injuries and no deaths associated with the prior recall. As of April 21, Arrow International has not reported any additional patient injuries or deaths.
CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Teleflex Customer Service at Recalls@teleflex.com or 1-866-396-2111.
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