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U.S. Department of Health and Human Services

Class 2 Device Recall MiniCap with ProvidoneIodine solution

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 Class 2 Recall
MiniCap with ProvidoneIodine solution
see related information
Date Posted June 21, 2013
Recall Status1 Open
Recall Number Z-1565-2013
Recall Event ID 65254
Premarket Notification
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. Intended to isolate the Easy-Lock connector of the solution transfer set.
Code Information Lot Number GD893891
Recalling Firm/
Manufacturer
Baxter Healthcare Corp.
1 Baxter Pkwy
Deerfield, Illinois 60015-4625
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall
leaking pouches
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Packaging Change Control
Action The firm, Baxter Healthcare Corporation sent an "URGENT PRODUCT RECALL" letter dated May 21, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. For general questions regarding this communication, contact The Center for One Baxter at 1-800-422-9837.
Quantity in Commerce 629,280 units
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KDI and Original Applicant = BAXTER HEALTHCARE CORP.
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