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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter MiniCap with ProvidoneIodine Solution

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  Class 2 Device Recall Baxter MiniCap with ProvidoneIodine Solution see related information
Date Initiated by Firm June 17, 2014
Date Posted July 17, 2014
Recall Status1 Terminated 3 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
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 2		 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 and Original Applicant = BAXTER HEALTHCARE CORP.
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