Class 2 Device Recall Finish Thompson Centrifugal Pump

• Date Initiated by Firm: April 19, 2019
• Date Posted: January 19, 2020
• Recall Status: Terminated on May 29, 2020
• Recall Number: Z-0823-2020
• Recall Event ID: 83990
• Product Classification: unknown device name - Product Code N/A
• Product: Finish Thompson Centrifugal Pump Model #110192-3 (sold as spare part)
• Code Information: Pump Serial Numbers: 178323B18, 178751C18, 178749C18, 180214D18, 180213D18, 180208D18, 178747C18, 178750C18
• Recalling Firm/ Manufacturer: Isopure Corp; 11851 Plantside Dr; Louisville KY 40299-6328
• For Additional Information Contact: Kim Riseling; 502-267-7873 Ext. 6640
• Manufacturer Reason for Recall: There is a potential for an uneven plastic encapsulation of the magnet ring during the molding process and partial axial displacement. This issue could cause uneven wear during use, cause exposure of the magnet to solution, and thereby result in corrosion and the presence of iron.
• FDA Determined Cause: Nonconforming Material/Component
• Action: The only affected customer was contacted via telephone on 4/19/19. An URGENT PRODUCT FIELD CORRECTION NOTICE dated 5/22/19 was distributed to affected clinics.
• Quantity in Commerce: 8
• Distribution: The products were distributed to the following US states: AL, FL, GA, MA, MD, MN, NC, NM, NY, OH, OK, TX, and VA.

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.