BEUDAMED
    FDA Recall Terminated

    MiniCap Extended Life PD Transfer Set

    Recall: Z-0768-2021 · Initiated November 10, 2020

    Recall

    Recall Number
    Z-0768-2021
    Event Number
    86883
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    KDJ
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    November 10, 2020
    Terminated
    March 24, 2023
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    MiniCap Extended Life PD Transfer Set

    Reason

    Potential for no-flow and leaks under the twist clamp.

    Action

    Urgent Medical Device Recall FA-2020-055 was sent to Peritoneal Dialysis Centers via U.S.P.S., first class mail on November 10, 2020. Urgent Medical Device Recall FA-2020-055 was sent via U.S.P.S., first class mail on November 13, 2020 to Home Patients who received impacted lots directly from Baxter. Out of an abundance of caution, Baxter will also be mailing the communication to all home patients who receive treatment at Peritoneal Dialysis Centers which received the impacted lots of transfer sets, regardless if the patient received the set or not.

    Distribution

    Worldwide and US (Nationwide), Canada, Brazil, Mexico, Bermuda, and Indonesia

    Quantity

    72,771 units