Class 2 Device Recall Baxter MiniCap with ProvidoneIodine Solution

• Date Initiated by Firm: June 17, 2014
• Date Posted: July 17, 2014
• Recall Status: Terminated on April 03, 2015
• Recall Number: Z-2074-2014
• Recall Event ID: 68590
• 510(K)Number: K895631
• Product Classification: Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
• Product: Baxter MiniCap with Povidone-Iodine Solution, 5C4466P, Baxter Healthcare Corporation. For dialysis.
• Code Information: GD895771
• FEI Number: 1417572
• Recalling Firm/ Manufacturer: Baxter Healthcare Corp.; 1 Baxter Pkwy; Deerfield IL 60015-4625
• For Additional Information Contact: Center for One Baxter; 224-948-4770
• Manufacturer Reason for Recall: Inadequate iodine and packaging related defects.
• FDA Determined Cause: Packaging process control
• Action: The firm notified their direct consignees on 06/17/2014 by letter requesting customers to locate and remove all affected product from their facility, and contact Baxter Healthcare Center for Service to arrange for return and credit.
• Quantity in Commerce: 585,360 units
• Distribution: Distributed USA (nationwide) and Canada.
• 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