Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Baxter, MiniCap with PovidoneIodine solution

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Baxter, MiniCap with PovidoneIodine solution see related information
Date Initiated by Firm July 08, 2013
Date Posted June 30, 2014
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = BAXTER HEALTHCARE CORP.
-
-