Recall Z-1292-2015 ยท FKX System, Peritoneal, Automatic Delivery
Baxter Healthcare Corp.
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.
| Date | Mar 18, 2015 (initiated Oct 16, 2013) |
| Status | Terminated |
| 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. |
| Root 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 i |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102936 | HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R Baxter Healthcare Corp, Mar 30, 2011 |