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U.S. Department of Health and Human Services

Class 2 Device Recall Transfer Set

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  Class 2 Device Recall Transfer Set see related information
Date Initiated by Firm April 28, 2014
Date Posted June 02, 2017
Recall Status1 Terminated 3 on July 21, 2017
Recall Number Z-2246-2017
Recall Event ID 76394
510(K)Number K882498  
Product Classification Set, administration, for peritoneal dialysis, disposable - Product Code KDJ
Product Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short. 1 Unit. Sterile. Baxter Healthcare Corporation, Deerfield, IL 60015 USA
Code Information Product Code 5C4483; Lot# H12030047
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
Manufacturer Reason
for Recall		 Connection issues between the PD transfer set catheter connector and an adapter may lead to leaks and contamination of the fluid pathway which may result in peritonitis.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action On April 28, 2014, firm sent an Urgent Product Recall to US customers via USPS 1st class mail. Baxter requested customers to locate and remove all affected product from their facility, and contact Baxter Healthcare Center for Service to arrange for return and credit. 100%, all non-respondents would be contacted by phone. All affected product would be destroyed. For general questions regarding this communication , contact The Center for One Baxter at 1-800-422-9837 , Monday through Friday, between the hours of 8:00AM and 5:00 PM Central Time.
Quantity in Commerce 6,048
Distribution Nationwide Distribution and Internationally to Canada and Malaysia
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 = KDJ and Original Applicant = BAXTER HEALTHCARE CORP.
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