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.

Reason: 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.

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

Distribution pattern: 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.