FDA Device recall Z-1292-2015

The HomeChoice Pro APD System is a peritoneal dialysis system

FDA Device
Class II
terminated
Published 2015-03-25

On 2015-03-25 the FDA classified a Class II recall of The HomeChoice Pro APD System is a peritoneal dialysis system by Baxter Healthcare, citing 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….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1292-2015
Classification	Class II
Status	terminated
Initiated	2013-10-16
Published	2015-03-25
Last updated	2026-09-13 11:53 UTC
Company	Baxter Healthcare
Distribution	US

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.

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.

Identifiers

code_info	Product Code: 5C8310; Serial Numbers: 80415, 680416, 680418, 680420, 680421, 680422, 680424, 680426, 680427, 680428,… 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, 6

code_info

Product Code: 5C8310; Serial Numbers: 80415, 680416, 680418, 680420, 680421, 680422, 680424, 680426, 680427, 680428,…

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, 6

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1292-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.