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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path

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  Class 2 Device Recall Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path see related information
Date Initiated by Firm October 06, 2015
Create Date October 30, 2015
Recall Status1 Terminated 3 on June 27, 2016
Recall Number Z-0194-2016
Recall Event ID 72362
510(K)Number K791899  
Product Classification Set, administration, for peritoneal dialysis, disposable - Product Code KDJ
Product Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path
Code Information H15C11095
Recalling Firm/
Manufacturer		 Baxter Healthcare Corp.
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall		 Leakage from the inlet port of the 15L Cycler Drainage Bags.
FDA Determined
Cause 2		 Under Investigation by firm
Action Baxter sent an Urgent Product Recall letter dated October 8, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The recalling firm will ask customers to locate and separate all affected products, contact the recalling firm to arrange for a return, and complete the customer reply form. Further questions, please call (800) 422-9837.
Quantity in Commerce 19,440 units
Distribution US Distribution and Internationally to 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 = KDJ and Original Applicant = TRAVENOL LABORATORIES, S.A.
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