Class 2 Device Recall Reprocessed Visions PV .035 Digital IVUS Catheter

• Date Initiated by Firm: April 26, 2021
• Create Date: August 23, 2021
• Recall Status: Terminated on March 09, 2022
• Recall Number: Z-2334-2021
• Recall Event ID: 88345
• Product Classification: Reprocessed intravascular ultrasound catheter - Product Code OWQ
• Product: NES Reprocessed Visions PV .035 IVUS Catheter, Sterile. For use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a crosssectional image of such vessels. NES Ref. No. R-88901
• Code Information: Lots L0017886 through L0020553
• FEI Number: 3005467144
• Recalling Firm/ Manufacturer: Northeast Scientific Inc.; 2142 Thomaston Ave; Waterbury CT 06704-1013
• For Additional Information Contact: SAME; 203-756-2111
• Manufacturer Reason for Recall: 510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles.
• FDA Determined Cause: No Marketing Application
• Action: Northeast Science contacted customers by telephone and email on 4/26/21. Customers were asked if inventory remained of the affected lot numbers. Had any of the customers had inventory they would have been instructed to return the products. No inventory was found of the affected lots.
• Quantity in Commerce: 690 devices
• Distribution: US Nationwide distribution in the states of CA, CT, FL, GA, IL, MA, NC, NJ, NY, TX.
• 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.