Class 2 Device Recall Baxter, MiniCap with PovidoneIodine solution

• Date Initiated by Firm: July 08, 2013
• Date Posted: June 30, 2014
• Recall Status: Terminated on June 30, 2014
• Recall Number: Z-1945-2014
• Recall Event ID: 68640
• 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. For dialysis.
• Code Information: Lot Numbers: GD894535, GD894550
• 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: the white printed paper layer on the pouch packaging may not be fully adhered to the pouch foil layer. The upper paper layer may serve as a protective barrier and help support overall packaging.
• FDA Determined Cause: Packaging change control
• Action: An Urgent Product Recall notification was mailed via U.S.P.S. first-class mail to facilities, (dialysis centers and distributors) on July 8, 2013 and mailed by first-class mail to home patients on July 11, 2013.
• Quantity in Commerce: 20,940 units
• Distribution: Distributed in the states of AR, TN MO, KS, TX, MS, and AL.
• 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