BEUDAMED
    FDA Recall Open, Classified

    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482; use in Peritoneal Dialysis

    Recall: Z-0567-2025 · Initiated October 23, 2024

    Recall

    Recall Number
    Z-0567-2025
    Event Number
    95524
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    KDJ
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    October 23, 2024
    Posted
    November 27, 2024
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482; use in Peritoneal Dialysis

    Reason

    There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.

    Action

    Baxter issued a SAFETY ALERT notice to its consignees on 10/23/2024 via USPS first class mail. The notice explains the issue and potential hazard involved. The notice addressed to dialysis providers indicated that if a patient contacts your clinic experiencing separation of the transfer set, to replace their transfer set and contact Baxter. Notices addressed to peritoneal patients provided the following instructions: "If you experience a separation of the transfer set, please close the transfer set twist clamp and do not cut the patient line. Contact your doctor and/or nurse immediately to arrange for a transfer set replacement and further guidance." Distributors were directed to notify their customers. For general questions regarding this communication, please contact Baxter Renal Home Care Services which can be reached at 800-284-4060, option 1, between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday.

    Distribution

    Worldwide distribution.

    Quantity

    1496 units