The HomeChoice Pro APD System is a peritoneal dialysis system. The HomeChoice Pro Automated Pe...
FDA Device Recall #Z-1292-2015 — Class II — October 16, 2013
Recall Summary
| Recall Number | Z-1292-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 16, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Baxter Healthcare Corp. |
| Location | Round Lake, IL |
| Product Type | Devices |
| Quantity | 75 units (US) |
Product Description
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 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.
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.
Lot / 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
Other Recalls from Baxter Healthcare Corp.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0370-2017 | Class II | GAMBRO Capillary Dialyzer, Polyflux(R) Revaclea... | Oct 12, 2016 |
| Z-0670-2017 | Class II | sigma spectrum VOLUMETRIC INFUSION PUMP with Ma... | Sep 28, 2016 |
| Z-0671-2017 | Class II | Baxter SIGMA Spectrum INFUSION PUMP with Master... | Sep 28, 2016 |
| Z-0672-2017 | Class II | V6 Rear Case Assembly, Product Code 35701, a re... | Sep 28, 2016 |
| Z-2533-2016 | Class II | Synovis VASCU-GUARD Peripheral Vascular Patch i... | Jun 24, 2016 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.