BEUDAMED
    FDA Enforcement Class II Ongoing

    Revaclear 400 Dialyzer. Product Code: 114749M. Not distributed in the USA. Used to treat chronic and acute renal failure by hemodialysis.

    Recall: Z-0761-2023 · Reported December 28, 2022

    Enforcement

    Recall Number
    Z-0761-2023
    Event ID
    91222
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 28, 2022
    Initiation Date
    November 23, 2022
    Classification Date
    December 22, 2022
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625, United States

    Description

    Revaclear 400 Dialyzer. Product Code: 114749M. Not distributed in the USA. Used to treat chronic and acute renal failure by hemodialysis.

    Reason

    Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer

    Code Info

    Not distributed in the USA. Product Code: 114749M; Lot Numbers: C422202401, C422202501, C422202601, C422202701, C422202801, C422202901, C422203001, C422203101, C422203201, C422203301, C422203401, C422203501, C422203601, C422203701, C422203801, C422203901, C422204001, C422204101, C422204201, C422204301, C422204401, C422204501, C422204701.

    Distribution

    Worldwide distribution. US Nationwide including Guam and St. Thomas USVI; Canada, China, Australia, New Zealand, Austria, Egypt, France, Germany, Ireland, Italy, Morocco, Qatar, Saudi Arabia, South Africa, Spain, United Kingdom, Bahamas, Barbados, Belize, Bermuda, Colombia, Dominican Republic, Ecuador, Guatemala, Honduras, Mexico, Panama, and Trinidad and Tobago.

    Quantity

    449,544 units