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U.S. Department of Health and Human Services

Class 2 Device Recall Integrated Automated PD Set with Cassette

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  Class 2 Device Recall Integrated Automated PD Set with Cassette see related information
Date Initiated by Firm December 08, 2014
Date Posted February 02, 2015
Recall Status1 Terminated 3 on October 28, 2015
Recall Number Z-1039-2015
Recall Event ID 70062
510(K)Number K102936  
Product Classification System, peritoneal, automatic delivery - Product Code FKX
Product Baxter Integrated APD Set with Cassette 3-Prong, Sterile, nonpyrogenic fluid path.

Product Usage: The recall device is 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 H13L22013
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		 Baxter is issuing a recall for one lot of Integrated Automated Peritoneal Dialysis set with Cassette 3 prong due to complaints received for leakage.
FDA Determined
Cause 2		 Device Design
Action Baxter sent an Urgent Product Recall notification letter dated January 8, 2015 . The letter identified the affected product, problem and action to be taken. The recalling firm has asked the consignees to 1) locate and remove all affected product from their facilities, 2) contact Baxter to arrange for return and credit, and 3) complete the attached customer reply form and return it to Baxter. For questions call 800-422-9637.
Quantity in Commerce 8,640 units
Distribution US Nationwide Distribution in the states of FL, WI, AR, TN, TX, NC, MO, NM, NJ, CT, PA, NV, NY, CA, MI, WI, KS, and OH.
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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