BEUDAMED
    FDA Enforcement Class II Terminated

    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short. 1 Unit. Sterile. Baxter Healthcare Corporation, Deerfield, IL 60015 USA

    Recall: Z-2246-2017 · Reported June 14, 2017

    Enforcement

    Recall Number
    Z-2246-2017
    Event ID
    76394
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 14, 2017
    Initiation Date
    April 28, 2014
    Classification Date
    June 2, 2017
    Termination Date
    July 21, 2017
    Address
    1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

    Description

    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short. 1 Unit. Sterile. Baxter Healthcare Corporation, Deerfield, IL 60015 USA

    Reason

    Connection issues between the PD transfer set catheter connector and an adapter may lead to leaks and contamination of the fluid pathway which may result in peritonitis.

    Code Info

    Product Code 5C4483; Lot# H12030047

    Distribution

    Nationwide Distribution and Internationally to Canada and Malaysia

    Quantity

    6,048