Class 2 Device Recall NAMIC

• Date Initiated by Firm: January 18, 2018
• Create Date: April 17, 2018
• Recall Status: Terminated on September 21, 2018
• Recall Number: Z-1390-2018
• Recall Event ID: 79558
• Product Classification: Angiography/angioplasty kit - Product Code OEQ
• Product: Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure Monitoring systems.
• Code Information: Lot Numbers: 5284422 5286610 5283649 5290525 5286542
• Recalling Firm/ Manufacturer: Angiodynamics Inc. (Navilyst Medical Inc.); 10 Glens Falls Tech Park; Glens Falls NY 12801-3864
• For Additional Information Contact: 518-792-4112
• Manufacturer Reason for Recall: NAMIC Fluid Management Convenience Kits contains a Fluid Delivery Set that was not assembled in accordance with specification, and prevents the device from being used, resulting in a minor delay in procedure.
• FDA Determined Cause: Under Investigation by firm
• Action: Recall Notifications were delivered by Fed Express. Consignees instructed to segregate and return all affected devices to Angiodynamics and complete and return the Reply Verification Tracking Form.
• Quantity in Commerce: 38 units
• Distribution: Recall conducted to end user level. Recall Notifications were delivered by Fed Express.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.