Class 2 Device Recall Revaclear

• Date Initiated by Firm: November 23, 2022
• Date Posted: December 22, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0764-2023
• Recall Event ID: 91223
• 510(K)Number: K130039
• Product Classification: Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
• Product: Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
• Code Information: No distribution in the USA. Product Code: 114749M; All lot numbers from C422202401 C422227201
• Recalling Firm/ Manufacturer: Baxter Healthcare Corporation; 1 Baxter Pkwy; Deerfield IL 60015-4625
• For Additional Information Contact: Center for One Baxter; 800-422-9837
• Manufacturer Reason for Recall: Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak
• FDA Determined Cause: Process control
• Action: Baxter Healthcare notified healthcare facilities on 11/23/2022 and home patients on 11/29/2022, via first class mail. Consignees were instructed to be aware of the difference in appearances between Polyurethane Displacement and an Internal Blood Leak and ensure staff is also aware. Additionally, consignees were instructed that if there is a blood leak alarm, to follow your clinical practice to stop treatment, and if only the Polyurethane Displacement is observed, to continue use of the dialyzer. Consignees were asked to acknowledge receipt of the notification by completing and returning the response form.
• Quantity in Commerce: 1,140,096 units
• Distribution: Worldwide distribution - US Nationwide and the countries of Canada, China, Australia, New Zealand, Austria, Egypt, France, Germany, Ireland, Italy, Morocco, Qatar, Saudi Arabia, South Africa, Spain, United Kingdom, Bahamas, Barbados, Belize, Bermuda, Colombia, Dominican Republic, Ecuador, Guatemala, Honduras, Mexico, Panama, St. Thomas, Trinidad and Tobago.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = KDI