Class 2 Device Recall REVACLEAR 400

• Date Initiated by Firm: May 31, 2019
• Create Date: July 01, 2019
• Recall Status: Terminated on October 05, 2020
• Recall Number: Z-1909-2019
• Recall Event ID: 83015
• 510(K)Number: K130039
• Product Classification: Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
• Product: REVACLEAR 400 Dialyzer, Product Code 114746L; ; Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.
• Code Information: UDI 07332414124076 Lot Numbers: C419205101 C419205201 C419205301
• Recalling Firm/ Manufacturer: Baxter Healthcare Corporation; 1 Baxter Pkwy; Deerfield IL 60015-4625
• For Additional Information Contact: Baxter Healthcare Center fr Service; 888-229-0001
• Manufacturer Reason for Recall: There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.
• FDA Determined Cause: Process control
• Action: The firm, Baxter, sent an " Urgent Product Recall" letter on 05/31/2019. The notice described the product, problem and actions to be taken. The customers were instructed to do the following: 1. Locate and remove all affected product lots from your facility. The product code and lot number can be found on the individual product or shipping carton. 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. Baxter Healthcare Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday. Please have your Baxter 8-digit ship-to account number, product code, lot number, and quantity of product to be returned ready when calling. 3. If you purchased this product directly from Baxter, complete the enclosed Baxter customer reply form and return it to Baxter by faxing it to 224-270-5457 or scanning and e-mailing it to fca@baxter.com, even if you do not have any inventory. Returning the customer reply form promptly will confirmyour receipt of this notification and prevent you from receiving repeat notices. 4. If you purchased this product from a distributor, please note that the Baxter customer reply form is not applicable. If a reply form is provided by your distributor or wholesaler, please return it to the supplier according to their instructions. 5. If you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them. 6. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please conduct a consumer-level recall of the affected product that you distributed to customers. For general questions regarding this communication, contact Baxter Corporate Product Surveillance at 800-437-5176, between the hours of 8:00 am and 5:00 pm Central Time, Monday through Friday. .
• Quantity in Commerce: 65403 units
• Distribution: US Nationwide Distribution and Internationally to: Canada and Bermuda.
• 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.

• 510(K) Database: 510(K)s with Product Code = KDI and Original Applicant = GAMBRO RENAL PRODUCTS, INC.