BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-1292-2015 · Initiated October 16, 2013

    Recall

    Recall Number
    Z-1292-2015
    Event Number
    66737
    Firm
    Baxter Healthcare Corp.
    FEI Number
    1416980
    Product Code
    FKX
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    October 16, 2013
    Posted
    March 18, 2015
    Terminated
    July 21, 2017
    Address
    25212 W. Illinois Route 120, Round Lake, IL, 60073-9799

    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

    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.

    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.

    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.

    Quantity

    75 units (US)