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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 Setsee related information
Date Initiated by FirmDecember 16, 2016
Date PostedJanuary 19, 2017
Recall Status1 Terminated 3 on August 24, 2017
Recall NumberZ-1056-2017
Recall Event ID 75998
510(K)NumberK102936 
Product Classification System, peritoneal, automatic delivery - Product Code FKX
ProductAPD 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 ContactCenter for One Baxter
800-422-9837
Manufacturer Reason
for Recall		Customer complaints received for the presence of leaks
FDA Determined
Cause 2		Device Design
ActionAn Urgent Product Recall communication will be sent to affected customers via U.S.P.S., first class mail.
Quantity in Commerce8640 eaches
DistributionUS only
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FKX
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