Class 2 Device Recall Baxter Healthcare HomeChoice Pro APD System

• Date Initiated by Firm: October 16, 2013
• Date Posted: March 18, 2015
• Recall Status: Terminated on July 21, 2017
• Recall Number: Z-1292-2015
• Recall Event ID: 66737
• 510(K)Number: K102936
• Product Classification: System, peritoneal, automatic delivery - Product Code FKX
• Product: The HomeChoice Pro APD System is a peritoneal dialysis system.; ; The HomeChoice Pro Automated Personal Cycler peritoneal dialysis system is intended for automatic control of dialysate solution exchange in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.
• Code Information: Product Code: 5C8310; Serial Numbers: 80415, 680416, 680418, 680420, 680421, 680422, 680424, 680426, 680427, 680428, 680429, 680430, 680438, 680439, 680440, 680441, 680444, 680445, 680448, 680449, 680452, 680453, 680454, 680455, 680456, 680457, 680459, 680460, 680461, 680462, 680463, 680465, 680467, 680467, 680469, 680470, 680472, 680473, 680475, 680476, 680477, 680478, 680480, 680481, 680482, 680463, 680484, 680485, 680486, 680489, 680490, 680491, 680494, 680495, 680496, 680498, 680499, 680500, 680501, 680502, 680503, 680504, 680505, 680506, 680507, 680508, 680509, 680510, 680516, 680517, 680519, 680520, 680521, 680522, 680524, 680525, 680526, 680527, 680527, 680528, 680529, 680530, 680532, 680533, 680534, 680536, 680537, 680538, 680539, 680541, 680542, 680543, 680547, 680552, 680553, 680544, 680555, 680561, 680562, 680566, 680567, 680585, 680586, 680587, 680588, 680589, 680590, 680591, 680593, 680594, 680595, 680596, 680597, 680598, 680599, 680600, 680601, 680602, 680603, 680604, 680605, 680606, 680607, 680608, 680609, 680611, 680612, 680613, 680614, 680615, 680616, 680617, 680618, 680619, 680620, 680621, 680622, 680623, 680624, 680625, 680626, 680627, 680628, 680629, 680630, 680631, 680632, 680633, 680634
• Recalling Firm/ Manufacturer: Baxter Healthcare Corp.; 25212 W. Illinois Route 120; Round Lake IL 60073-9799
• For Additional Information Contact: Center for One Baxter; 800-422-9837
• Manufacturer Reason for Recall: The occluder in affected devices 1) may have sharp edges that could cut the pneumatic tubing that connects the occluder blade to the manifold causing an unrecoverable system error, and/or 2) blade may separate from the back plate and cause Slow / No Flow alarm requiring therapy termination.
• FDA Determined Cause: Process design
• Action: An Urgent Device Correction letter dated 10/16/13 was mailed to dialysis centers and medical facilities. A similar Urgent Device Correction letter dated 10/31/13 was mailed to dialysis home patients. The letters requested for customers to examine their devices to determine if the devices are being recalled. If the devices are on the attached list of recalled devices, the customer is to contact Baxter Technical Services at 1-800-553-6898 (7 days a week, 24 hours a day) to arrange for a swap cycler. The letter further requests that customers complete the attached Customer Reply Form and return it to Baxter by fax or e-mail.
• Quantity in Commerce: 75 units (US)
• Distribution: Worldwide Distribution-US (nationwide) including the states of AK, AR, AZ, CA, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, MI, MO, NC, NJ, NV, NY, OH, PA, SC, TN, TX, UT, VA, VT, WA, and WI, and the countries of Australia, Canada, and Mexico.
• 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.