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U.S. Department of Health and Human Services

Class 2 Device Recall APD Set with Cassette 3Prong Peritoneal Dialysis Set

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  Class 2 Device Recall APD Set with Cassette 3Prong Peritoneal Dialysis Set see related information
Date Initiated by Firm December 16, 2016
Date Posted January 19, 2017
Recall Status1 Terminated 3 on August 24, 2017
Recall Number Z-1056-2017
Recall Event ID 75998
510(K)Number K102936  
Product Classification System, peritoneal, automatic delivery - Product Code FKX
Product APD Set with Cassette 3-Prong Peritoneal Dialysis Set

Indicated for use in the treatment of patients with renal failure to provide PD fluid exchanges with Baxter HomeChoice PD systems in clinical and home use settings.
Code Information H16F16088
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall		 Customer complaints received for the presence of leaks
FDA Determined
Cause 2		 Device Design
Action An Urgent Product Recall communication will be sent to affected customers via U.S.P.S., first class mail.
Quantity in Commerce 8640 eaches
Distribution US only
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 = FKX and Original Applicant = BAXTER HEALTHCARE CORP.
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