BEUDAMED
    FDA Recall Terminated

    GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product Usage: The Revaclear Max dialyzer is a single use device used for treatment of chronic and acute renal failure by hemodialysis.

    Recall: Z-0370-2017 · Initiated October 12, 2016

    Recall

    Recall Number
    Z-0370-2017
    Event Number
    75414
    Firm
    Baxter Healthcare Corp.
    FEI Number
    1417572
    Product Code
    KDL
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 12, 2016
    Posted
    November 8, 2016
    Terminated
    August 19, 2017
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product Usage: The Revaclear Max dialyzer is a single use device used for treatment of chronic and acute renal failure by hemodialysis.

    Reason

    Potential presence of particulate matter on the blood side of the dialyzer

    Action

    Baxter sent an Urgent Product Recall letter dated October 12, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to: I. Locate and remove all affected product lots from their facility. 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. 3. Complete the enclosed Baxter Customer Reply Form and return it to Baxter by either fax or scanned email. For questions contact Baxter Product Surveillance at 800-437-5176.

    Distribution

    Worldwide Distribution - US Nationwide and the countries of Canada and Mexico.

    Quantity

    22,656 units