BEUDAMED
    FDA Recall Terminated

    HomeChoice Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, T5C4441R

    Recall: Z-1018-05 · Initiated June 21, 2005

    Recall

    Recall Number
    Z-1018-05
    Event Number
    32251
    Firm
    Baxter Healthcare Renal Div
    FEI Number
    3000210122
    Product Code
    FKX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 21, 2005
    Posted
    July 19, 2005
    Terminated
    December 11, 2007
    Address
    1620 Waukegan Rd, Bldg R, Mc Gaw Park, IL, 60085-6730

    Description

    HomeChoice Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, T5C4441R

    Reason

    The screws that secure the Power Entry Module (PEM) to the base of the HomeChoice device are not reliably grounded to the device's ground system, posing an electric shock hazard.

    Action

    Baxter sent Urgent Device Correction letters worldwide to their customers on 6/21/05 and home patients on 6/22/05. The accounts were informed of teh risk of electrical shock from screws used to secure the Power Entry Module to the back of the HomeChoice system, and were instructed to always connect the power cord to the power entry module first, before plugging the power cord into a grounded electrical outlet. The users were advised to use caution to avoid contact the power entry module screws while powering on or powering off the device, and were informed that a new mounting bracket that providews more reliable grounding was installed in instruments processed through the Baxter service organization as of May 2005. All remaining instruments will receive the new mounting bracket by August 2006, and Baxter will contact the accounts to arrange for the upgrade. Any questions were directed to Baxter Global Technical Services at 1-800-553-6898, prompt 1.

    Distribution

    Nationwide, including Puerto Rico, and internationally to Argentina, Austria, Australia, Belgium, Canada, Chile, China, Colombia, Denmark, Ecuador, France, Germany, Guatemala, Hong Kong, Ireland, India, Italy, Korea, Mexico, Malaysia, Nicaragua, the Netherlands, New Zealand, Peru, the Philippines, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, the United Kingdom, Uruguay and Venezuela.

    Quantity

    52,617 units