Dialysis Catheter Kit Recall: Arrow International Removes Dialysis Catheter Kits Containing Merit Medical Splittable Sheath Introducers
Arrow International is removing specific dialysis catheter kits from the market because they contain component parts—specifically Merit Medical Splittable Sheath Introducers—that have been recalled.
Arrow International, healthcare facilities utilizing these dialysis catheter kits, and clinical personnel involved in vascular access procedures.
This action highights the regulatory risk inherent in finished device kits where a recall of a third-party component necessitates a recall of the entire integrated system. For regulatory professionals, this underscores the importance of robust supplier quality monitoring and the ability to track specific component lots across complex product configurations. the source indicates a secondary manufacturer (Arrow) must take corrective action due to an upstream failure by a component supplier (Merit).
Quality and supply chain teams should immediately identify and sequester affected Arrow Dialysis Catheter Kits and verify if any affected Merit Medical components remain in local inventory. Regulatory departments should update risk files to reflect the potential for component-driven recalls within larger kit assemblies.
Arrow International is removing dialysis catheter kits containing recalled Merit Medical Splittable Sheath Introducers
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