Class 2 Device Recall MiniCap with PovidoneIodine Solution

• Date Initiated by Firm: January 22, 2015
• Date Posted: March 13, 2015
• Recall Status: Open, Classified
• Recall Number: Z-1269-2015
• Recall Event ID: 70512
• 510(K)Number: K895631
• Product Classification: Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
• Product: MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis.
• Code Information: Lot Numbers: GD896845, Exp. 10/2015; GD897371, Exp. 01/2016; GD896936, Exp. 10/2015; GD897124, Exp. 11/2015; GD897165, Exp. 12/2015; GD897157, Exp. 12/2015; GD896944, Exp. 11/2015; GD896837, Exp. 10/2015
• Recalling Firm/ Manufacturer: Baxter Healthcare Corp.; 1 Baxter Pkwy; Deerfield IL 60015-4625
• For Additional Information Contact: Center for One Baxter ; 800-422-9837
• Manufacturer Reason for Recall: Product may have separating or protruding sponges
• FDA Determined Cause: Under Investigation by firm
• Action: Baxter sent an Urgent Product Recall letter dated January 22, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Baxter is requesting that you take the following actions: 1. Locate and remove all affected product from your facility. The product code and lot number can be found on the individual product package or shipping carton. 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. Center for Service can be reached at 888-229-0001, Monday through Friday, between the hours of 7:00 AM and 6:00 PM Central Time. Please have your Baxter eight-digit ship-to account number ready when calling. 3. If you received your product directly from Baxter, please complete the enclosed customer reply form, and return it to Baxter by either fax or scanned e-mail. 1. If you ordered product from a dealer, wholesaler, or distributor/reseller, please follow your supplier's reply and recall process. 2. Locate and remove all affected product from your facility. The product code and lot number can be found on the individual product package or shipping carton. 3. Contact Baxter Healthcare Center for Service to arrange for return and credit.Center for Service can be reached at 888-229-0001, Monday through Friday, between the hours of 7:00 AM and 6:00 PM Central Time. Please have your ship-to account number ready when calling. 4. Please do not return the Baxter customer reply form to Baxter. Reply forms should be returned to your supplier. For clinical questions, contact Baxter's Renal Clinical Helpline at 888-736-2543, option 2, Monday through Friday, between the hours of 8:00 AM and 5:00 PM Central Time. For general questions regarding this communication, contact The Center for One Baxter at 800-422-9837, Monday through Friday, between the hours of 8:00AM and 5:00 PM Central Time.
• Quantity in Commerce: 4,391,520 units
• Distribution: Worldwide Distribution - Nationwide Distribution and to the countries of : Canada, Austria, Norway, Portugal, Saudi Arabia and Spain.
• 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 and Original Applicant = BAXTER HEALTHCARE CORP.