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U.S. Department of Health and Human Services

Class 2 Device Recall Automated Peritoneal Dialysis (APD) Cycler

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  Class 2 Device Recall Automated Peritoneal Dialysis (APD) Cycler see related information
Date Initiated by Firm October 21, 2014
Date Posted January 29, 2015
Recall Status1 Terminated 3 on September 01, 2015
Recall Number Z-1031-2015
Recall Event ID 70232
510(K)Number K102936  
Product Classification System, peritoneal, automatic delivery - Product Code FKX
Product HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Product codes 5C8310, 5C8310R, R5C8320, and 5C4474.
Code Information all codes distributed between 4/15/2014 and 6/11/2014
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		 The keypad buttons on HomeChoice devices may be activated without the operator pressing them.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action An Urgent Device Correction notification was sent to consignees on October 31, 2014. Within the notification, Baxter Healthcare asked customers to do the following: 1) Contact Baxter Technical Services to arrange for the exchange (swap) of any affected HomeChoice PRO Automated PD System devices. 2) Complete the attached customer reply form and return it to Baxter by either fax or scanned e-mail. For general questions regarding this communication, contact The Center for One Baxter at 900-422-9837, Monday through Friday between the hours of 8:00 AM and 5:00 PM Central Time.
Quantity in Commerce 200
Distribution AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MO, NC, NE, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, VT, WA, WI and District of Columbia
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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